1.
Clinical Trials Information System; 09/10/2023; TrialID: CTIS2023-507441-29-00
Clinical Trial Register
| ICTRP | ID: ictrp-CTIS2023-507441-29-00
ABSTRACT
Condition:
PneumoniaMedDRA version: 20.0Level: PTClassification code: 10035664Term: PneumoniaSystem Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]-Diseases [C] - Bacterial Infections and Mycoses [C01]-Diseases [C] - Virus Diseases [C02];MedDRA version: 20.0Level: PTClassification code: 10035664Term: PneumoniaSystem Organ Class: 100000004862
Intervention:
Product Name: Dexamethasone 3.3 mg/ml solution for injection,Product Code: PRD302046,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Dexamethasone Sodium Phosphate 4.37mg,Product Name: Hydrocortisone 100 mg, powder for solution for injection/infusion,Product Code: PRD5848761,Pharmaceutical Form: SOLUTION FOR INJECTION/INFUSION,Other descriptive name: ,Strength: Hydrocortisone Sodium Succinate 133.7mg,Product Name: Tamiflu 75 mg hard capsules,Product Code: PRD2154676,Pharmaceutical Form: CAPSULE, HARD,Other descriptive name: ,Strength: Oseltamivir 75mg,Product Name: Dexamethasone Tablets BP 2.0mg,Product Code: PRD3570594,Pharmaceutical Form: TABLET,Other descriptive name: ,Strength: Dexamethasone Ph. Eur. 2mg,Product Name: Prednisolone 10mg Tablets,Product Code: PRD4940399,Pharmaceutical Form: TABLET,Other descriptive name: ,Strength: Prednisolone 10mgPrimary outcome:
Main Objective:To provide reliable estimates of the effect of study treatments on mortality and time to discharge from hospital;Secondary Objective:To assess the effect of study treatment on progression to invasive mechanical ventilation or extracorporeal membrane oxygenation;Primary end point(s):28 day all-cause mortality,Time to discharge alive from hospital within 28 days (patients with influenza only)Criteria:
Inclusion criteria: Hospitalised patients aged =18 years,Pneumonia syndrome (clinical diagnosis, in general based on a) typical symptoms of new respiratory infection, b) objective evidence of acute lung disease [e.g. hypoxia or compatible imaging or clinical examination], and c) alternative causes considered unlikely,One of the following diagnoses: a) Confirmed influenza A or B infection b) Community-acquired pneumonia with planned antibiotic treatment (without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia),No medical history that might, in the opinion of the patient’s doctor, put the patient at significant risk if he/she were to participate in the trial,No reason that the trial treatment definitely should, or should not, be given in the opinion of the patient’s doctor (this only affects eligibility for the relevant comparison)Exclusion criteria: No exclusion criteria
2.
ISRCTN; 15/09/2023; TrialID: ISRCTN12928349
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN12928349
ABSTRACT
Condition:
Flu and COVID-19 vaccine responsesInfections and Infestations
Intervention:
1. Fine needle aspiration (FNA) of axillary lymph nodes2. Non-diagnostic ultrasound
3. Study injection: seasonal influenza vaccine, COVID-19 vaccine given contemporaneously as intramuscular injections into the right and left arms. The influenza vaccine is given into the right arm and the COVID-19 vaccine into the left arm
All participants will receive one dose each of the two vaccines in different arms. Participants will be randomly allocated to undergo FNA to collect lymph node cells from both armpits at either 7 or 14 or 28 days, with another FNA for all participants at 84 days after study injections (vaccination). Participants will be assessed for eligibility at a screening visit; those eligible to take part will attend a further 7 visits over 13 weeks. Blood samples will be taken at each visit.
Primary outcome:
The frequency, phenotype, and function of immune cells in axillary secondary lymphoid tissue and blood after intramuscular immunisation, measured using single-cell ribonucleic acid sequencing (scRNA-seq) to measure cell-by-cell transcriptomes in lymph node cells and/or multiparameter flow cytometry, at Day 0, 7, Day 14 and Day 28 and Day 84 after the study injectionCriteria:
Inclusion criteria: 1. Adults aged between 18 to 45 years (inclusive) OR aged 65 years and over2. Medically stable (i.e., according to investigator's judgement, it is not anticipated that the participant will require hospitalisation within the study period or that they will need to withdraw from the study for medical reasons before completion of protocol-specified follow-up). A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 90 days prior to enrolment.
3. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diaries
4. Willing and able to give informed consent for participation in the study
5. Agree to allow study staff to contact his or her GP or equivalent NHS databases to access the participant’s vaccination records and medical history
6. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study
7. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
8. Agree to refrain from blood donation whilst in the study
9. For participants of childbearing potential only (as defined by protocol). Willing to use effective contraception established for the duration of enrolment in the study AND have a negative pregnancy test on the days of screening and study injections.
10. Have received at least a primary (two-dose) schedule of any MHRA, UK-authorised or licenced COVID-19 vaccine.
Exclusion criteria: 1. Participation in another research study involving an investigational product, or which includes procedures that could compromise the integrity of this study (such as significant volumes of blood already taken), within the 12 weeks prior to enrolment, or planned participation in such a study within the study period.
2. Body mass index >=35 kg/m²
4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
5. Administration of regular anticoagulation medication likely to induce bruising or bleeding on fine needle aspiration.
6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months, or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within the previous 3 months).
7. History of anaphylaxis in relation to vaccination, or local anaesthetic such as lidocaine.
8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the experimental vaccine or to local anaesthetic such as lidocaine.
9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
10. History of cancer that is not resolved (except basal cell carcinoma of the skin and cervical carcinoma in situ).
11. History of any serious psychiatric condition likely to affect participation in the study.
12. For participants of childbearing potential only: participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study.
13. History of a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
14. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism); history of antiphospholipid syndrome, or history of heparin-induced thrombocytopenia.
15. History of episodes of capillary leak syndrome.
16. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator (note, mild/moderate well-controlled co-morbidities are acceptable)
17. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units per week.
18. Suspected or known injecting drug use within the 5 years preceding enrolment.
19. Detectable circulating hepatitis B surface antigen (HBsAg).
20. Seropositive for hepatitis C virus (antibodies to HCV).
21. Seropositive for HIV.
22. A history of pericarditis, myocarditis or other cardiac inflammation deemed significant by the investigator
23. Any clinically significant finding on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study.
24. Member of the study team. This is deliberately loosely defined, but at a minimum will include: anyone on the delegation log; anyone who might be anticipated to be placed onto the delegation log in the course of the study; anyone who has access to personal data on study participants
3.
ClinicalTrials.gov; 14/07/2023; TrialID: NCT05978037
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05978037
ABSTRACT
Condition:
Malaria;Malaria,Falciparum;Parasitic Disease;Vector Borne Diseases;InfectionsIntervention:
Biological: RH5.1 and/or RH5.2-VLP with Matrix-MPrimary outcome:
To assess the safety of RH5.2-VLP and RH5.1 in Matrix-M in healthy volunteers at different doses and used in various regimens by assessing the occurrence of solicited local reactogenicity signs and symptoms;To assess efficacy of RH5.2-VLP in Matrix-M by assessing its impact on parasite multiplication rate (PMR) in vaccinated volunteers compared to infectivity controls, against P. falciparum in a blood-stage controlled human malaria infection (CHMI) model.Criteria:
Inclusion Criteria:
- • Healthy adult aged 18 to 45 years
- Able and willing (in the Investigator's opinion) to comply with all study
requirements.
- Willing to allow the Investigators to discuss the volunteer's medical history
with their GP
- Participants of childbearing potential only: must practice continuous effective
contraception for the duration of the study (see section 11.10)
- Agreement to refrain from blood donation for the duration of the study
- Able and willing to provide written informed consent to participate in the trial
Additional inclusion criteria for groups 2 and 6:
- Negative haemoglobinopathy screen (including sickle cell disease and alpha and beta
thalassaemia) and normal G6PD levels
- Agreement to permanently refrain from blood donation, as per current UK Blood
Transfusion and Tissue Transplantation Services guidelines (89)
- Reachable (24 hours a day) by mobile phone during the period between CHMI and
completion of antimalarial treatment
- Willingness to take a curative anti-malaria regimen following CHMI
- Able to answer all questions on the informed consent questionnaire correctly at first
or second attempt
- Able to travel to CCVTM without using public transport
Exclusion Criteria:
- • History of clinical malaria (any species) or previous participation in any malaria
(vaccine) trial or CHMI
- Travel to a clearly malaria endemic locality during the study period or within
the preceding six months
- Use of immunoglobulins or blood products (e.g. blood transfusion) in the last
three months
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of
any other vaccine within 30 days following each study vaccination, with the
exception of COVID-19 and flu vaccines, which should not be received between 14
days before to 7 days after any study vaccination
- Receipt of an investigational product in the 30 days preceding enrolment, or
planned receipt during the study period
- Concurrent involvement in another clinical trial involving an investigational
product or planned involvement during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of
the trial data, as assessed by the Investigator
- Any confirmed or suspected immunosuppressive or immunodeficient state, including
HIV infection; asplenia; recurrent, severe infections and chronic (more than 14
days) immunosuppressant medication within the past 6 months (inhaled and topical
steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any
component of the vaccine
- Any history of anaphylaxis in relation to vaccinations
- Pregnancy, lactation or intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma
in situ)
- History of serious psychiatric condition that may affect participation in the
study
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol misuse as defined by an alcohol intake of
greater than 25 standard UK units every week
- Suspected or known injecting drug use in the 5 years preceding enrolment
- Hepatitis B surface antigen (HBsAg) detected in serum
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless
volunteer has taken part in a prior hepatitis C vaccine study with confirmed
negative HCV antibodies prior to participation in that study, and negative HCV
ribonucleic acid (RNA) PCR at screening for this study)
- Volunteers unable to be closely followed for social, geographic or psychological
reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood
tests or clinical examination. In the event of abnormal test results,
confirmatory repeat tests will be requested.
- Any other significant disease, disorder, or finding which may significantly
increase the risk to the volunteer because of participation in the study, affect
the ability of the volunteer to participate in the study or impair interpretation
of the study data
- Inability of the study team to contact the volunteer's GP to confirm medical
history and safety to participate
Additional exclusion criteria for Groups 2 and 6:
- Body weight <50 kg or Body Mass Index (BMI) <18.0 at screening
- Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI
(e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin,
erythromycin, fluoroquinolones and azithromycin)
- Use of anti-malarials within 30 days of CHMI
- Receipt of a COVID-19 vaccine within 2 weeks before the day of CHMI or planned receipt
of a COVID-19 vaccine or prior to expected completion of antimalarial treatment
(around 2 to 3 weeks after day of challenge based on experience in previous P.
falciparum CHMI studies to date)
- An estimated ten-year risk of fatal cardiovascular disease of =5% at screening, as
determined by the Systematic Coronary Risk Evaluation (SCORE).
- Use of medications known to cause prolongation of the QT interval and existing
contraindication to the use of Malarone
- Use of medications known to have a potentially clinically significant interaction with
Riamet and Malarone
- Any other contraindications/known hypersensitivities to both Riamet and Malarone
- Any clinical condition known to prolong the QT interval
- History, or evidence at screening, of clinically significant arrhythmias, including
clinically relevant bradycardia, prolonged QT interval or other clinically relevant
ECG abnormalities
- Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia
- Family history of congenital QT prolongation or sudden death
- Positive family history in both 1st AND 2nd degree relatives < 50 years old for
cardiac disease
- History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait,
G6PD deficiency or any haematological condition that could affect susceptibilit
4.
ClinicalTrials.gov; 14/07/2023; TrialID: NCT06141057
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06141057
ABSTRACT
Condition:
Malaria;Malaria,Falciparum;Protozoan Infections;Parasitic Disease;Infections;Vector Borne DiseasesIntervention:
Biological: Matrix M with RH5.1Primary outcome:
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of solicited reactogenicity following each vaccinations;To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of unsolicited adverse events following each vaccinations;To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by comparing safety laboratory measures following each vaccinations;To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of serious adverse eventsCriteria:
Inclusion Criteria:
- Healthy adult aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study
requirements.
- Willing to allow the Investigators to discuss the volunteer's medical history with
their GP
- Participants of childbearing potential only: must practice continuous effective
contraception for the duration of the study (see section 9.9)
- Agreement to refrain from blood donation for the duration of the study
- Able and willing to provide written informed consent to participate in the trial
Exclusion Criteria:
- History of clinical malaria (any species) or previous participation in any malaria
(vaccine) trial or controlled human malaria infection (CHMI) study
- Travel to a clearly malaria endemic locality during the study period or within the
preceding six months
- Use of immunoglobulins or blood products (e.g. blood transfusion) in the last three
months
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any
other vaccine within 30 days following each study vaccination, with the exception of
COVID-19 vaccines, which should not be received between 14 days before to 7 days after
any study vaccination
- Receipt of an investigational product in the 30 days preceding enrolment, or planned
receipt during the study period
- Concurrent involvement in another clinical trial involving an investigational product
or planned involvement during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the
trial data, as assessed by the Investigator
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
infection; asplenia; recurrent, severe infections and chronic (more than 14 days)
immunosuppressant medication within the past 6 months (inhaled and topical steroids
are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine
- Any history of anaphylaxis
- Pregnancy, lactation or intention to become pregnant during the study
- Body mass index of <18.5 or >35
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
situ)
- History of serious psychiatric condition that may affect participation in the study
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol misuse as defined by an alcohol intake of greater
than 25 standard UK units every week
- Suspected or known injecting drug use in the 5 years preceding enrolment
- Hepatitis B surface antigen (HBsAg) detected in serum
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer
has taken part in a prior hepatitis C vaccine study with confirmed negative HCV
antibodies prior to participation in that study, and negative HCV ribonucleic acid
(RNA) PCR at screening for this study)
- Volunteers unable to be closely followed for social, geographic or psychological
reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood
tests, urinalysis or clinical examination. Blood test abnormalities will be assessed
as per the laboratory adverse event table in Appendix A (table 8). In the event of
abnormal test results deemed to be clinically significant, confirmatory repeat tests
may be requested. Procedures for identifying laboratory values meeting exclusion
criteria are described in Appendix A.
- Any other significant disease, disorder, or finding which may significantly increase
the risk to the volunteer because of participation in the study, affect the ability of
the volunteer to participate in the study or impair interpretation of the study data
- Inability of the study team to contact the volunteer's GP to confirm medical history
and safety to participate
5.
ClinicalTrials.gov; 22/06/2023; TrialID: NCT05955612
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05955612
ABSTRACT
Condition:
SepsisIntervention:
Procedure: Procalcitonin measurementPrimary outcome:
Length of antibiotic treatmentCriteria:
Inclusion Criteria:
- Participant, legally authorised person/ legal guardian willing and able to give
informed consent for participation in the trial.
- Male or Female, aged 16 to 65 years
- Suspected or proven bacterial infection
- A positive sepsis screening National Early Warning Score (NEWS) equal or greater than
5 (Table 1 or at least one criterion with a score of 3.
- Intention to start parenteral antibiotic therapy
- Within 24 hours of hospital admission
Exclusion Criteria:
- Patients with suspected/documented tuberculosis, parasitic infection (including
malaria or visceral leishmaniasis), or viral infections (i.e., COVID-19, dengue, HIV)
- Pregnancy
- Intended for a short stay in ICU or general ward (such as post-operative)
- Patients requiring a predefined long course of antibiotic therapy (such as
endocarditis, osteomyelitis, lung abscess, liver abscess, septic arthritis)
- Immunocompromised patients, including as severe neutropenia (< 500 cells/ml),
transplant recipients, on prolonged corticosteroid treatment, chemotherapy or disease
modifying immunomodulatory medications
- More than 48 hours of parenteral antibiotic use
- Surgical patients, including patients with a surgical septic source or patients
requiring source control, i.e. abscess drainage
- Moribund patients or patients receiving end of life care
- Previous enrolment in PROCALBAN
- Conditions accompanied with a systemic inflammatory state, including pancreatitis,
cardiogenic shock, severe trauma
6.
ClinicalTrials.gov; 15/05/2023; TrialID: NCT06017037
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06017037
ABSTRACT
Condition:
AnhedoniaIntervention:
Drug: Citalopram 20mg;Drug: PlaceboPrimary outcome:
Reward & aversive learning: behavioural correlates;Reward & aversive learning: neural correlatesCriteria:
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the
research
- Aged between 18 to 65 years
- Sufficient knowledge of English language to understand and complete study tasks
Exclusion Criteria:
- Current or past probable diagnosis of psychiatric illness, according to DSM-5
criteria, requiring intervention by a healthcare professional, including but not
limited to psychosis, bipolar disorder, major depression, OCD, PTSD, substance abuse
disorder or any eating disorder
- Current or past diagnosis of any significant personality disorder (e.g. borderline
personality disorder) according to self-report
- Diagnosis of attention deficit hyperactive disorder or autistic spectrum disorder that
impairs daily functioning, requires pharmacotherapy or in the opinion of the study
medic would affect the scientific integrity of the study
- Current use of medication that might interact with the effects of citalopram or affect
the scientific integrity of the study
- Previous suicide attempt or previous prolonged period (e.g. > 5 days) of thoughts to
end life
- Known contraindication to citalopram including: past allergic reaction to citalopram
or any other medicines, diagnosis of a cardiovascular condition, glaucoma, type 1 or
type 2 diabetes, diagnosis of epilepsy, previous diagnosis of angle-closure glaucoma,
or current use of any other medication whose use interacts with citalopram (according
to BNF guidance) e.g. associated with prolonged QT-interval
- Any other current or past medical conditions which in the opinion of the study medic
may interfere with the safety of the participant or the scientific integrity of the
study including epilepsy/seizures, brain injury, hepatic or renal disease, diabetes,
severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological
conditions
- First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic
disorder, or bipolar disorder
- Severely underweight (BMI<17) or very obese (BMI>40) in a manner that renders them
unsuitable for the study in the opinion of the study medic
- Heavy use of cigarettes (smoke > 20 cigarettes per day)
- Heavy use of caffeine (drink > 4 250ml cups/cans of coffee/energy drinks per day)
- Lactose intolerance (due to the study involving administration of a lactose placebo
tablet)
- Known allergy to citric acid, sodium chloride, sucrose or quinine
- Pregnancy (as determined by urine pregnancy test taken during the Part 2 screening
visit), breast feeding or plans to become pregnant
- past history of dependence on illicit substances or regular illicit substance use
within previous three months
- Evidence of current or past harmful use of alcohol
- previous participation in a study involving the tasks used in this study or involving
use of citalopram in the last year
- physical (including visual and auditory) or language impairment that would make
complying with the study protocol challenging
- ongoing deficit in sense of smell or taste e.g. following Covid-19 infection
- Participant is unlikely to comply with the clinical study protocol or is unsuitable
for any other reason, in the opinion of the Investigator
- Not suitable for MRI neuroimaging e.g. claustrophobia, difficulty remaining still for
duration of scan
- Any MRI contraindications outlined in FMRIB 3 Tesla scanning safety form
7.
ISRCTN; 24/04/2023; TrialID: ISRCTN17936606
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN17936606
ABSTRACT
Condition:
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infectionInfections and Infestations
Intervention:
Participants will be randomized within their group (which is based on past vaccination with ChAdOx1 nCov-19) to receive either ChAdOx1 MERS or saline placebo in a 5:1 ratio.Arm 1: two doses of ChAdOx1 MERS vaccine 5x10e10 vp
Arm 2: two doses 0.9% saline placebo
Both vaccine and placebo are administered via intramuscular route as two doses given at 0 and 12 weeks.
Follow-up activities: the study consists of a screening visit, two vaccination visits and five follow-up visits (at days 14 and 28 after the fists vaccination and at days 14, 28 and 281 after the second vaccination). During the follow-up visits vital signs (heart rate, temperature, blood pressure) will be taken, except on day 281 post second vaccination. Targeted medical history and physical examination may be performed, if required. Any COVID-19 infections and vaccinations will be recorded. Solicited AEs will be collected in an electronic diary within 7 days of each vaccination. Unsolicited AEs will be collected within 28 days of each vaccination in the electronic diary. A review of ongoing AEs and collection of SAEs and AESI will be performed for the whole duration of the study follow-up period. Blood samples will be collected at each of the follow-up visits. A review of electronic diary entries and laboratory blood tests will be performed at the follow-up study visits.
Primary outcome:
1. Occurrence of solicited local reactogenicity signs and symptoms within 7 days of each vaccination, self-reported in the participant’s electronic symptom diary2. Occurrence of solicited systemic reactogenicity signs and symptoms within 7 days of each vaccination, self-reported in the participant’s electronic symptom diary
3. Occurrence of unsolicited adverse events (AEs) within 28 days of each vaccination, self-reported in the participant’s electronic symptom diary and from clinical evaluation at follow-up visits
4. Change from baseline for safety laboratory measures within 28 days of each vaccination, measured from blood tests taken at each visit
5. SAEs and AESIs for the whole duration of the study follow-up period, self-reported in the participant’s electronic symptom diary and from clinical evaluation at follow-up visits
Criteria:
Inclusion criteria: 1. Adults aged between 50 to 70 years (inclusive) at the time of screening2. Medically stable, such that according to investigator judgement hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 90 days prior to enrolment.
3. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
4. Willing to allow confirmation of their past medical history either through: provision of or access to medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or accessed via the electronic patient record or other medical documentation provided by the participant
5. Agreement to refrain from blood donation during the course of the study
6. Willing and able to give informed consent for participation in the study
7. For women of childbearing potential only (As defined by protocol section 8.4): Willing to use effective contraception as defined from one month prior to receiving the first vaccine and for the duration of the study AND a negative pregnancy test on the days of screening and vaccination.
8. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
9. Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study
10. Group 1 specific inclusion criteria: a confirmed history of receiving at least TWO doses of the ChAdOx1 nCov-19 (Oxford/AZ COVID-19) vaccine prior to enrolment
11. Group 2 specific inclusion criteria: no previous history of receiving ANY doses of the ChAdOx1 nCov-19 (Oxford/AZ COVID-19) vaccine prior to enrolment
Exclusion criteria: 1. Participation in another research study involving an investigational product or that which may compromise the integrity of the study (e.g. significant volumes of blood already taken in previous study) in the past 12 weeks, or are planning to do so within the trial period
2. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days of any study vaccine.
3. Previous immunisation with an investigational MERS vaccine
4. History of prior confirmed or suspected MERS infection
5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infections or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months)
7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the IMP or Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine)
8. History of allergic reaction to aminoglycoside antibiotics
9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
10. History of anaphylaxis in relation to vaccination
11. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
12. History of serious psychiatric condition likely to affect participation in the study
13. Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study
14. Bleeding disorder (e.g. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
15. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), history of antiphospholipid syndrome, or history of heparin induced thrombocytopenia
16. Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine)
17. Individuals who have previously experienced episodes of capillary leak syndrome
18. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator (note, mild/moderate well-controlled comorbidities are allowed)
19. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
20. Suspected or known injecting drug abuse in the 5 years preceding enrolment
21. Detectable circulating hepatitis B surface antigen (HBsAg)
22. Seropositive for hepatitis C virus (antibodies to HCV)
23. Any clinically significant finding on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study
24. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or i
8.
ISRCTN; 12/04/2023; TrialID: ISRCTN73764282
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN73764282
ABSTRACT
Condition:
Mental healthMental and Behavioural Disorders
Intervention:
On completion of baseline assessments participants will be randomised using the sortition system to receive either Sleep Restriction Therapy (SRT) + Treatment As Usual (TAU) or TAU alone. SRT will involve six weekly sessions with a trained nurse. TAU may include existing treatment regimens for depression (and insomnia). There will be no restriction upon usual care for either group. Usual care for depression is likely to be antidepressant medication and/or referral to psychological therapy services. Usual care for insomnia is likely to be general sleep advice, hypnotics, or sedative antidepressants. The six sessions will comprise three in-person sessions (1/3/5) and three remote sessions (2/4/6), although all sessions could be delivered remotely if needed (e.g., due to participant preference, scheduling difficulties, covid restrictions, or room availability at practice).Following the baseline assessment, each participant will be followed up at 4, 8 and 26 weeks post-randomisation where they will complete the study questionnaires and perform the study tests carried out at the baseline assessment.
Primary outcome:
Self-reported depression severity measured using the Patient Health Questionnaire-9 (PHQ-9) at 26 weeks post-randomisationCriteria:
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial.2. Aged 18 years or above.
3. Screen positive for depressive symptoms on the PHQ-9 (> = 10) and meet criteria for Major Depressive Disorder, assessed via the Structured Clinical Interview for DSM-5 (SCID-5)
4. Screen positive for insomnia symptoms on the sleep condition indicator and meet criteria for Insomnia Disorder
5. Self-reported sleep efficiency < 85% over the past month, assessed via the Pittsburgh Sleep Quality Index (PSQI)
6. Able to attend appointments for assessments and treatment and adhere to study procedures
7. The participant’s GP surgery is participating in the trial
Exclusion criteria: 1. Female participant who is pregnant or planning pregnancy during the trial
2. Additional sleep disorder diagnosis OR “positive” on screening.
3. Dementia or Mild Cognitive Impairment (MCI)
4. Alcohol or substance-use dependent
5. Epilepsy
6. Psychosis (schizophrenia, bipolar disorder)
7. Currently or recently received in-patient psychiatric treatment within the past 2 months
8. Current suicidal ideation with intent OR attempted suicide within the past 2 months
9. Currently receiving cancer treatment OR planned major surgery during the treatment phase
10. Night, evening, early morning or rotating shift-work
11. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia
12. Previously received sleep restriction therapy from a health professional
13. Life expectancy of < 1 year
14. Another person in the household already participates in this trial
15. Currently taking part in another clinical trial which could affect outcomes in RESTED
16. Recruiting clinician deems not suitable for the trial
9.
ClinicalTrials.gov; 12/04/2023; TrialID: NCT05828940
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05828940
ABSTRACT
Condition:
PTSDIntervention:
Drug: Losartan Potassium;Drug: PlaceboPrimary outcome:
BOLD activation in hippocampus during new>familiar contrastCriteria:
Inclusion Criteria:
- willing and able to provide informed consent
- male or Female, aged 18-50 years
- body mass index (BMI) of 18-30 kg/m2
- non- or light-smoker (< 5 cigarettes a day)
- STAIT score of at least 40
Exclusion Criteria:
- Female participant who is pregnant or breast-feeding
- CNS-active medication during the last 6 weeks
- Current blood pressure or other heart medication (especially aliskiren or beta
blockers)
- Diagnosis of intravascular fluid depletion or dehydration
- Past or present DSM-IV axis-I diagnosis or suspected diagnosis (from SCID results at
screening)
- Alcohol or substance abuse
- First-degree family member with a history of a severe psychiatric disease
- Impaired liver or kidney function
- Lifetime history of epilepsy or other neurological disease, systemic infection, or
clinically significant hepatic, cardiac, obstructive respiratory, renal,
cerebrovascular, metabolic, endocrine or pulmonary disease or disorder which, in the
opinion of the investigator, may either put the participants at risk because of
participation in the study, or may influence the result of the study, or the
participant's ability to participate in the study.
- High or moderate risk of coronavirus, based on the NHS checklist for coronavirus
vulnerability
https://www.nhs.uk/conditions/coronavirus-covid-19/people-at-higher-risk/whos-at-highe
r-risk-from-coronavirus/
- Contraindication to MRI (e.g. metal implant)
- Insufficient English skills
- participated in another study involving CNS-active medication during the last 6 weeks
Participants will also not be able to take part if they are left-handed, due to the
research MRI aspect of the study relying on group means.
10.
ClinicalTrials.gov; 17/03/2023; TrialID: NCT05876195
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05876195
ABSTRACT
Condition:
Immune ResponseIntervention:
Biological: Keyhole-Limpet Hemocyanin;Drug: Saline;Drug: Montanide ISA 51 VG;Drug: AlhydrogelPrimary outcome:
To establish the immunogenicity of subunit KLH at different doses, with and without aluminium hydroxide or Montanide ISA-51 adjuvantsCriteria:
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the
study and is able to comply with the study protocol.
- Male or female between 18 and 45 years of age inclusive, at the time of signing the
informed consent.
- Healthy as determined by a physician, based on a detailed medical history and a
complete physical examination including vital signs and laboratory measurements.
- Body weight >= 50 kg and body mass index (BMI) within the range 18 to 30
kilogram/meter squared (inclusive).
- Female participants of child bearing potential: Females of child bearing potential are
eligible to enter if they are not pregnant (negative pregnancy test on the day of both
screening and vaccination) and willing to use effective methods of contraception to
prevent pregnancy from the time of first dose to 60 days afterwards.
- Male participants with female partners of child-bearing potential: must agree to use
effective methods of contraception from the time of the first dose of challenge agent
to 60 days afterwards.
- At least 2 previous doses of a registered SARS-CoV2 vaccination, at least 60 days
previously
- Sufficient English language ability to enable appropriate informed consent procedures
to be conducted in English
Exclusion Criteria:
- Antibiotics or antiviral therapy after a serious illness within 30 days of study
entry.
- SARS CoV2 (COVID-19) infection within the previous 30 days, diagnosed using PCR test
or lateral flow device
- Any use of immunosuppressant or immunomodulatory agents (systemic or topical) in 3
months prior to study entry.
- Chronic medical conditions with potential effect on immune responses including
diabetes, significant history of atopy, or any condition that, in the opinion of the
investigator, would interfere with the study
- Presence of tattoos, naevi or other skin abnormalities such as keloids (or history of
keloids) that may, in the opinion of the investigator, interfere with study
assessments.
- Fitzpatrick skin type V and VI (due to potential interference with assessment of DTH
response)
- Pregnancy or breastfeeding
- Allergy to KLH, aluminium hydroxide, Montanide ISA-51, related vaccine adjuvants, or
components of the study challenge agents
- Allergy to shellfish
- Residency in or significant previous travel to areas endemic for schistosomiasis (due
to potential cross-reactive immune responses to KLH)
- Previous exposure to Keyhole Limpet Haemocyanin, e.g. in the context of a previous
study
- Participants participating, within 7 days of screening, in recreational sun-bathing,
or use of sun-bed, on the area of the skin from wrist to shoulder inclusive.
- Phobia of needles or minor surgical procedures.
- Current smoker or using nicotine replacement therapy
- Participants receiving any vaccinations within 2 months prior to screening visit, or
will require vaccination prior to the end of study follow-up.
- Any other significant disease, disorder, or finding, which, in the opinion of the
investigator, may either put the participant at risk, affect their ability to
participate in the study or impair interpretation of the study data
11.
ClinicalTrials.gov; 05/12/2022; TrialID: NCT05648448
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05648448
ABSTRACT
Condition:
Influenza;Influenza, HumanIntervention:
Drug: Drug: Oseltamivir;Drug: Drug: Favipiravir;Drug: Drug: Zanamivir;Drug: Drug: Baloxavir;Drug: Drug: Molnupiravir;Drug: Drug: Peramivir;Drug: Drug: LaninamivirPrimary outcome:
Rate of viral clearance for currently available drugs and those with potential activityCriteria:
Inclusion Criteria:
- Patient understands the procedures and requirements and is willing and able to give
informed consent for full participation in the study
- Adults, male or female, aged 18 to 50 years at time of consent.
- Early symptomatic Influenza (A or B); at least one reported symptom of influenza
(including fever, history of fever, myalgias, headache, cough, fatigue, nasal
congestion, rhinorrhoea and sore throat) within 4 days (96 hours)
- Influenza positive by rapid antigen test OR a positive RT-PCR test for influenza
viruses within the last 24hrs with a Ct value of <30
- Able to walk unaided and unimpeded in activities of daily living (ADLs)
- Agrees and is able to adhere to all study procedures, including availability and
contact information for follow-up visits
Exclusion Criteria:
The patient may not enter the study if ANY of the following apply:
- Taking any concomitant medications or drugs which could interact with the study
medications or have antiviral activity
- Presence of any chronic illness/condition requiring long term treatment or other
significant comorbidity
- BMI =35 Kg/m2
- Clinically relevant laboratory abnormalities discovered at screening
- Haemaglobin <10g/dL
- Platelet count <100,000/uL
- ALT > 2x ULN
- Total bilirubin >1.5 x ULN
- eGFR <70mls/min/1.73m2
- For females: pregnancy, actively trying to become pregnant or lactation (healthy women
on OCP are eligible to join)
- Contraindication to taking, or known hypersensitivity reaction to any of the proposed
therapeutics
- Currently participating in another interventional influenza or COVID-19 therapeutic
trial
- Clinical evidence of pneumonia- e.g. shortness of breath, hypoxaemia, crepitations
(imaging not required)
- Known to be currently co-infected with SARS-CoV-2 (i.e. confirmed with positive ATK or
RT-PCR)
- Received live attenuated influenza virus vaccine within 3 weeks prior to study entry
12.
ClinicalTrials.gov; 05/10/2022; TrialID: NCT05571735
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05571735
ABSTRACT
Condition:
Covid-19 Pandemics;TuberculosisIntervention:
Biological: Pfizer-BioNTech COVID-19 vaccine;Biological: AstraZeneca vaccine;Biological: Janssen Ad26.COV2.S COVID-19 vaccinePrimary outcome:
Comparison of humoral and cellular responses to SARS-CoV-2 between bacteriologically confirmed TB patients under treatment vs healthy individuals at the end of the study;Comparison of humoral and cellular responses to SARS-CoV-2 between bacteriologically confirmed TB patients under treatment vs healthy individuals.Criteria:
Inclusion Criteria:
- 18 years and above, newly diagnosed bacteriologically confirmed TB patients including
both drug sensitive and resistant TB, who are taking anti TB or MDR-TB treatment in
initial period during study period or clinically healthy individuals for comparator
arm.
- Willing to be followed for four weeks following second dose of Pfizer-BioNTech
COVID-19 vaccine and AstraZeneca vaccine or eight weeks following single dose of
Janssen Ad26.COV2.S COVID-19 vaccine
- Willing to be involved in the pre-enrolment screening.
- For women with child bearing potential only (aged 18-49 years), willing to continue to
use effective contraception methods through the study.
- For women with child bearing potential only (aged 18-49 years), negative pregnancy
test on the day of screening and on the day of vaccination to be eligible to receive
the vaccination.
- Able and willing to comply with all study requirements.
- Ability to understand the study instructions and provide written informed consent
Exclusion Criteria:
- History of laboratory confirmed COVID-19 for any duration before or positive COVID-19
PCR or antigenic test at screening.
- History of HIV infection
- Participation in other COVID-19 related studies for the duration of the study.
- Participation in other vaccine trials within 90 days before and 30 days after the
study vaccination.
- Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days
before administration of the vaccine.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Any previous history of a serious side effect with any kind of vaccine.
- Any history of angioedema.
- Any history of anaphylaxis.
- Women with pregnancy, lactation or planning to get pregnant during the duration of the
study.
- Current diagnosis of or treatment for cancer.
- History of severe psychiatric disorders likely to affect participation in the study.
- Bleeding disorder (e.g. coagulation factor deficiency, coagulopathy or platelet
disorder), history of thrombosis or prior history of significant bleeding or bruising
following IM injections or venipuncture.
- Suspected or known current alcohol or drug dependency (except well controlled
condition).
- Presence of any condition which in the judgement of the investigator would place the
patient at undue risk or interfere with the results of the study.
- Severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver
disease, renal disease, endocrine disorder and neurological illness (mild/moderate
well controlled comorbidities are allowed).
13.
ISRCTN; 16/09/2022; TrialID: ISRCTN14105049
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN14105049
ABSTRACT
Condition:
COVID-19 (SARS-CoV-2 infection)Infections and Infestations
Intervention:
The study will be conducted in the Clinical Research Facility at the Churchill Hospital in Oxford. The COV-CHIM01 trial participants (also the study population) are admitted 2 days prior to exposure to the SARS-CoV-2 virus. The virus exposure will be entirely managed by the COV-CHIM01 trial team.Informed consent will be taken from willing participants after they are admitted to the Clinical Research Facility, but before the exposure to the virus. Following this, recruited participants will then have the VitalPatch (adhesive chest patch collecting heart rate and respiratory rate) and Aktiia (wrist-worn unit collecting blood pressure) devices attached and will be instructed in their use by a member of the research team. Baseline blood pressure and temperature will be recorded by the research team in order to calibrate the wearable devices.
Recruited participants will be encouraged to wear the two devices (as tolerated) as much as possible including during sleep, from Day -1 of the COV-CHIM01 study (the day before inoculation) to Day 12.
The VitalPatch can be worn continuously, but participants will need to remove the Aktiia for showering, during which time the device can be placed on charge. This will be clearly discussed during the initial consent and specified in the Participant Information Sheet.
They will be visited on Day 6 of their quarantine period by a member of the research team, who will supervise the replacement of the VitalPatch and check the Aktiia device. During this visit participants will be asked to complete a wearability questionnaire.
On Day 12 of their quarantine period they will be visited again and the devices will be removed.
Participants who would prefer to wear only one of either the VitalPatch or the Aktiia will still be inclu
Primary outcome:
The feasibility of early detection of COVID-19 infection using data collected by wearable devices and the measured variation in vital signs from continuous monitoring during the course of the study (up to Day 12)Criteria:
Inclusion criteria: 1. Participation in the COV-CHIM01 study2. Participant is willing and able to give informed consent for participation in this study
3. Aged 18 years or over
Exclusion criteria: 1. Intra-cardiac device
2. Known history of cardiac arrhythmias
3. Allergy to adhesives
14.
ISRCTN; 15/09/2022; TrialID: ISRCTN12022293
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN12022293
ABSTRACT
Condition:
Severe SARS-CoV-2 infectionInfections and Infestations
Intervention:
Study participants will be randomly allocated to receive one of the following at Visit 1: a 4th dose of either Pfizer/Wyeth or AstraZeneca/Fiocruz vaccines, =6 months after heterologous or homologous booster in individuals primed with two doses of Sinovac/Butantan.
Participants, laboratory staff, and clinicians assessing causality will be blinded to the treatment allocation. Randomisation will be performed using a secure internet-based randomisation system ensuring allocation concealment by a member of the local research team. Participants will be allocated in a 1:1 ratio.
Primary outcome:
Part 1:
1. Anti-Spike IgG antibody titers of SARS-CoV-2 measured using blood samples collected at =6 months after the 3rd vaccine dose
Part 2:
1. Anti-Spike IgG antibody titers of SARS-CoV-2 measured using blood samples collected at ~28 days after the 4th vaccine dose
2. Neutralizing titer (NT) against SARS-CoV-2 (including against relevant variants of concern) measured using blood samples collected at 28 days and 6 months after the 4th vaccine dose (in a sub-set of participants)
Criteria:
Inclusion criteria:1. Participants in study RHH_001 per-protocol population who were fully evaluable. Participants included in previous neutralization assay subsets will be targeted for enrolment first if operationally feasible.
2. Willing and able to provide informed consent prior to any study procedure
3. Willing and able to comply with the study procedure
4. Received heterologous or homologous third vaccine dose =6 months prior to this study
5. For people of childbearing potential:
5.1. Willing to practice continuous effective contraception during the study
5.2. Negative pregnancy test on the day(s) at screening
Additional inclusion criteria for part 2 only:
1. Informed consent to receive 4th vaccine dose, AstraZeneca/Fiocruz or Pfizer/Wyeth
2. No contraindication against AstraZeneca/Fiocruz or Pfizer/Wyeth SARS-C0V-2 vaccine
Exclusion criteria:
1. Any additional SARS-CoV-2 vaccine after the 3rd dose in study RHH_001
2. Fever >37.5 °C (axillary) or any acute disease at baseline (Day 0) or within the 3 days prior to randomization. Febrile participants with mild diseases may be enrolled at the investigator’s discretion once fever has resolved.
3. Participants with a history of serious vaccine-related adverse reaction or serious allergic reaction (e.g. anaphylaxis) to any study vaccine component, as described in the last summary of product characteristics for AstraZeneca/Fiocruz or Pfizer/Wyeth
4. Known bleeding disorder that, in the investigator’s opinion, would contraindicate intramuscular injection
5. Any progressive or serious neurological disorder, seizure disorder, or history of Guillian-Barré syndrome
6. Given treatment with immunosuppressant therapy within the last 90 days, including cytotoxic agents or systemic corticosteroids, or planned receipt during the study period. If a short-term cycle of immunosuppressant systemic corticosteroid dose has been used to treat acute disease, the participant should not be enrolled in the study until corticosteroid therapy has been discontinued for =15 days prior to the first study vaccination. In case the participant has been on an immunosuppressant dose of a depot, intramuscular or intra-articular corticosteroid, they should wait 60 days for their enrolment in the study. Inhaled/nebulized, intra-articular, intrabursal or topical (skin or eyes) corticosteroids are allowed.
7. Autoimmune diseases other than: Hashimoto thyroiditis, vitiligo, psoriasis, discoid lupus, and similar diseases.
8. HIV-positive and/or in treatment for HIV
9. Given any other investigational product within the 30 days prior to Day 1, or intending to take part in another clinical trial at any time during this study conduction
10. Given any other licensed vaccine within 14 days prior to enrolment in this study or planning to receive any vaccine up to 28 days after vaccination
11. Given treatment with Rituximab or any other anti-CD20 monoclonal antibody within 9 months prior to Day 1 or planned during the study period
12. Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrolment or planned dosing during the study period
13. Participants with any condition that, in the investigator’s opinion, could interfere with the status primary objectives or represent an additional risk for the participant
Temporary exclusion criteria:
1. Participants with a recent history of COVID-19 (=4 weeks prior to visit 1) will be delayed until 4 weeks after diagnosis
15.
ISRCTN; 05/08/2022; TrialID: ISRCTN85770358
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN85770358
ABSTRACT
Condition:
Conditions for which video and hybrid group consultations are delivered (e.g. diabetes, asthma, long Covid)Not Applicable
Intervention:
We are evaluating the use of video and hybrid group consultations, drawing on methods such as survey questionnaires, interviews, focus groups, observation and analysis of healthcare utilisation data.Primary outcome:
1. Experiences of staff, patients and national and local policy-makers and commissioners measured using qualitative interviews, focus groups and observation carried out for the duration of the project and there is no specific timepoint for participation
2. Video and hybrid group consultations (VHGCs) delivery and resource use measured using structured proformas once a month
3. Patient experience, satisfaction, activation and health-related quality of life measured using survey questionnaires following participation in VHGC or individual appointments
4. Healthcare utilisation (primary and secondary care) measured using data from general practice records and secondary care data, over 12 months
Criteria:
Inclusion criteria:1. Aged 18 years old and over
2. Willing and able to give informed consent for participation
3. Patient participants will be included if they have been diagnosed with a relevant condition, receiving care from participating services
4. Carer participants will be included if they care for someone diagnosed with a relevant condition, receiving care from participating services
5. Staff will be included if they are involved in implementing or supporting video and hybrid group consultations (VHGCs) in participating GP practices
6. Commissioning and policy stakeholders will be included if they are involved in planning or commissioning remote services including VHGCs, or wider aspects of general practice commissioning relevant to this study
Exclusion criteria:
1. Inability to read or speak English unless a relevant translator/translated study materials are available
2. Co-morbidity preventing participation (for patient participants)
3. No specific exclusions for staff and commissioning/policy participants
16.
ClinicalTrials.gov; 15/06/2022; TrialID: NCT05557513
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05557513
ABSTRACT
Condition:
COVID-19 PandemicIntervention:
Device: STANDARD Q COVID-19 Ag TestPrimary outcome:
Evaluate the differences in number of cases detected per 1,000 people between the Ag-RDT and No Ag-RDT intervention arms.Criteria:
1. For Ag RDT arm (primary objective)
1. Inclusion Criteria
- *Symptomatic COVID-19 patient/suspected COVID-19 or **close contact/family
members of COVID-19 patient
- Participant at any age living in chosen clusters of Maramat and Pohphra
Myanmar migrant community
- Participant or parent/guardian/caretaker is willing and able to give
informed consent for participation in the study.
2. Exclusion Criteria
- Known history of a COVID-19 positive test result within the last 21 days
2. For No Ag RDT arm (primary objective)
1. Inclusion Criteria
- Participant at any age living in chosen cluster of Maramat and Pohphra
Myanmar migrant community
- Symptomatic COVID-19 patient/suspected COVID-19 or **close contact/family
members of COVID-19 patient who agrees to go for routine Thai COVID-19 ATK
or RT-PCR test
- Participant or parent/guardian/caretaker is willing and able to give
informed consent for participation in the study
2. Exclusion Criteria
- Not living in chosen clusters in Maramat and Pohphra Myanmar migrant
community
note: *Symptomatic or suspected COVID-19: Acute onset of ANY THREE OR MORE of the
following signs or symptoms: Fever, cough, general weakness/fatigue1, headache,
myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting1, diarrhoea, altered
mental status (1 Signs separated with slash (/) are to be counted as one sign)
Reference: WHO-2019-nCoV-Surveillance_Case_Definition-2020.2-eng (5).pdf
note: **1 Person who stayed close to or had conversation with COVID-19 patient(s) for
>5 minutes, or was exposed to the patient's cough or sneeze; 2 Individual who stayed
in enclosed spaces with poor ventilation together with COVID-19 patient(s) for >30
minutes, for instance, in air-conditioned bus, commuter vane, or air-conditioned room;
Reference: g_HCWs_3Mar22.pdf (moph.go.th)
3. For seroprevalence survey (secondary objective)
1. Inclusion Criteria
- Participant at any age living in chosen clusters of Maramat and Pohphra
Myanmar migrant community
- Participant or parent/guardian/caretaker is willing and able to give
informed consent for participation in the study.
2. Exclusion Criteria
- Refusal to give informed consent, or contraindication to venepuncture
4. For Focus group discussion (FGD)
1. Inclusion Criteria
- Age 18 years and above
- Living in chosen clusters of Maramat and Pohphra migrant communities
- Participant is willing and able to give informed consent for participation
in the study.
2. Exclusion Criteria
- Not living in chosen clusters of Maramat and Pohphra migrant communities
17.
ClinicalTrials.gov; 13/06/2022; TrialID: NCT05421546
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05421546
ABSTRACT
Condition:
COVID-19;Vaccine ReactionIntervention:
Dietary Supplement: Spermidine or PlaceboPrimary outcome:
The primary objective of this study is to determine the safety of daily Spermidine supplements following the vaccine booster for Coronavirus (SARS-CoV-2) and its effects on antibody levels in older people, using validated assays.Criteria:
Inclusion Criteria:
- Participants must be 65 years old or more and must have the capacity to provide
written consent after discussing the participant information sheet with a member of
the clinical study team. Participants must have received 2 doses of the COVID vaccine
and a booster dose.
Exclusion Criteria:
- Participants who are acutely unwell.
- Participants who have had a clear clinical history of COVID symptoms or a previous
positive COVID PCR( polymerase chain reaction) swab or antibody test
- Participants who cannot provide informed written consent
- Participants who use systemic steroids for more than one week e.g prednisolone
>0.5mg/kg/day in the three months prior to first study intervention
- Chronic administration (=14 days in total) of immunosuppressants or other immune
modifying drugs in the 3 months prior to first study intervention
- Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin
preparation in the three months prior to first study intervention
- Participants who have been diagnosed with medical conditions that can suppress the
immune system or diabetes
- Participants with previous allergy to or constituent parts of Spermidine supplements
or who have gluten intolerance
- Participants already taking Spermidine supplements at the time of recruitment or for 6
months prior to recruitment to the study
- Participants that are in custody
- Participants that do not live in the UK
- Participants that are pregnant
- Participants who are shielding
18.
ClinicalTrials.gov; 26/05/2022; TrialID: NCT05400746
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05400746
ABSTRACT
Condition:
Malaria;Plasmodium FalciparumIntervention:
Biological: Pfs48/45 in Matrix-MPrimary outcome:
To assess safety and tolerability of the Pfs48/45 with Matrix-M vaccine at various doses in healthy adult volunteers by assessing the occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination;To assess safety and tolerability of the Pfs48/45 with Matrix-M vaccine at various doses in healthy adult volunteers by assessing the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination;To assess safety and tolerability of the Pfs48/45 with Matrix-M vaccine at various doses in healthy adult volunteers by assessing the occurrence of unsolicited adverse events (AEs) for 28 days following the vaccination;To assess safety and tolerability of the Pfs48/45 with Matrix-M vaccine at various doses in healthy adult volunteers. assessed through the number of participants with abnormal laboratory test results;To assess safety and tolerability of the Pfs48/45 with Matrix-M vaccine at various doses in healthy adult volunteers assessed through the number of participants with serious adverse events;To assess safety and tolerability of the Pfs48/45 with Matrix-M vaccine at various doses in healthy adult volunteers.Criteria:
Inclusion Criteria:
- Healthy adult aged 18 to 45 years.
- Able and willing (in the Investigator's opinion) to comply with all study
requirements.
- Willing to allow the Investigators to discuss the volunteer's medical history with
their GP.
- Volunteers with the potential to become pregnant only: must practice continuous
effective contraception for the duration of the study (see section 10.10).
- Agreement to refrain from blood donation for the duration of the study.
- Able and willing to provide written informed consent to participate in the trial
Exclusion Criteria:
- History of clinical malaria (any species).
- Travel to a clearly malaria endemic locality during the study period or within the
preceding six months.
- Use of immunoglobulins or blood products (e.g., blood transfusion) in the last three
months.
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any
other vaccine within 30 days following each study vaccination, with the exception of
COVID-19 vaccines, which should not be received between 14 days before to 7 days after
any study vaccination.
- Receipt of an investigational product in the 30 days preceding enrolment, or planned
receipt during the study period.
- Concurrent involvement in another clinical trial or planned involvement during the
study period.
- Prior receipt of an investigational vaccine likely to impact on interpretation of the
trial data, as assessed by the Investigator.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
infection; asplenia; recurrent, severe infections and chronic (more than 14 days)
immunosuppressant medication within the past 6 months (inhaled and topical steroids
are allowed).
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Any history of anaphylaxis in reaction to vaccinations.
- Pregnancy, lactation or intention to become pregnant during the study.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
situ).
- History of serious psychiatric condition that may affect participation in the study.
- Any other serious chronic illness requiring hospital specialist supervision.
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater
than 25 standard UK units every week.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Hepatitis B surface antigen (HBsAg) detected in serum.
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer
has taken part in a prior hepatitis C vaccine study with confirmed negative HCV
antibodies prior to participation in that study, and negative HCV ribonucleic acid
(RNA) PCR at screening for this study).
- Volunteers unable to be closely followed for social, geographic or psychological
reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood
tests, urinalysis or clinical examination. In the event of abnormal test results,
confirmatory repeat tests will be requested. Procedures for identifying laboratory
values meeting exclusion criteria are shown in SOP VC027.
- Any other significant disease, disorder, or finding which may significantly increase
the risk to the volunteer because of participation in the study, affect the ability of
the volunteer to participate in the study or impair interpretation of the study data.
- Inability of the study team to contact the volunteer's GP to confirm medical history
19.
ISRCTN; 20/05/2022; TrialID: ISRCTN14304264
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN14304264
ABSTRACT
Condition:
Long COVIDInfections and Infestations
Intervention:
This is a multi-centre prospective, observational, cohort study comprising six patient groups. Cohort A consists of participants who were hospitalised with COVID-19, Cohort B consists of participants who had COVID-19 but were not hospitalised and Cohort C will be control participants. The study will recruit patients in Cohort A & B through hospital-based Long-COVID clinics and Cohort C will be recruited via advertising.
The participants will be invited to undertake their baseline study visit at one of the four recruiting centres, Oxford, Sheffield, Cardiff or Manchester. At the baseline visit participants provide consent (unless obtained prior to baseline visit), and their demographics, past medical history and smoking history will be collected. They will have their heart rate, blood pressure and oxygen saturations recorded. They will undertake lung function testing (unless testing has been performed within 6 weeks prior to baseline scan), a 6-minute walk test or a 1-minute sit to stand test, a low dose CT scan and HPX-pMRI Chest. They will also be asked to complete a set of questionnaires.
Following their baseline visit, all participants will be asked to complete up to two additional follow-up visits (from 3-12 months after their baseline visit). If an abnormality (a result outside the normal range) was found on the HPX-pMRI Chest scan at baseline the participant will be invited to have a repeat HPX-pMRI Chest and repeat all other study assessments. If no abnormality is found on the baseline HPX-pMRI Chest scan, participants will not be asked to repeat study assessments and will instead complete the follow-up visit remotely where they will be asked to repeat only the study questionnaires electronically.
Primary outcome:
1. Diffusion and or perfusion defects detected using HPX-pMRI at baseline and if abnormal at 3 and 12 months
2. The determination of whether detected abnormalities correlate with symptoms of breathlessness measured using lung function tests and questionnaires at baseline and if the HPX-pMRI scans are abnormal at baseline, 3 and 12 months
3. The degree of pulmonary damage and change detected on follow up HPX-pMRI scanning at 3 and 12 months
Criteria:
Inclusion criteria:1. Participant is willing and able to give informed consent for participation in the study
2. Aged 18 years or above
3. One of the following criteria:
3.1. Microbiological evidence of COVID-19 infection OR
3.2. Diagnosis of long COVID or 'post-COVID syndrome' (as defined by NICE 2020) made through specialised assessment at a designated long COVID clinic
Exclusion criteria:
1. Participants who are pregnant, lactating or planning pregnancy during the course of the study
2. Known or identified chronic renal impairment, with EGFR below 60 ml/min – if necessary this renal function will be measured according to local hospital policy
3. Known prior contrast media reaction
4. Inability to lie flat for imaging
5. Contraindications to MRI examinations as locally determined
6. Any other reason, as determined by the study investigators, that renders the participant ineligible for the study
20.
ClinicalTrials.gov; 17/05/2022; TrialID: NCT05385471
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05385471
ABSTRACT
Condition:
Malaria, FalciparumIntervention:
Biological: Matrix M with R78C and/or RH5.1Primary outcome:
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination;To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination;To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of unsolicited adverse events for 28 days following the vaccination;To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with abnormal laboratory test results;To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with serious adverse eventsCriteria:
Inclusion Criteria:
The volunteer must satisfy all the following criteria to be eligible for the study:
- Healthy adult aged 18 to 45 years
- Able and willing (in the Investigator's opinion) to comply with all study
requirements.
- Willing to allow the Investigators to discuss the volunteer's medical history with
their GP
- Participants of childbearing potential only: must practice continuous effective
contraception until 3 months after the final study vaccination (see section 9.10)
- Agreement to refrain from blood donation for the duration of the study
- Able and willing to provide written informed consent to participate in the trial
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
- History of clinical malaria (any species) or previous participation in any malaria
vaccine trial or controlled human malaria infection trial
- Travel to a clearly malaria endemic locality during the study period or within the
preceding six months
- Use of immunoglobulins or blood products (e.g. blood transfusion) in the last three
months
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any
other vaccine within 30 days following each study vaccination, with the exception of
COVID-19 vaccines, which should not be received between 14 days before to 7 days after
any study vaccination
- Receipt of an investigational product in the 30 days preceding enrolment, or planned
receipt during the study period
- Concurrent involvement in another clinical trial involving an investigational product
or planned involvement during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the
trial data, as assessed by the Investigator
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
infection; asplenia; recurrent, severe infections and chronic (more than 14 days)
immunosuppressant medication within the past 6 months (inhaled and topical steroids
are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine
- Any history of anaphylaxis in reaction to vaccinations
- Pregnancy, lactation or intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
situ)
- History of serious psychiatric condition that may affect participation in the study
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol misuse as defined by an alcohol intake of greater
than 25 standard UK units every week
- Suspected or known injecting drug use in the 5 years preceding enrolment
- Hepatitis B surface antigen (HBsAg) detected in serum
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer
has taken part in a prior hepatitis C vaccine study with confirmed negative HCV
antibodies prior to participation in that study, and negative HCV ribonucleic acid
(RNA) PCR at screening for this study)
- Volunteers unable to be closely followed for social, geographic or psychological
reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood
tests, urinalysis or clinical examination. In the event of abnormal test results,
confirmatory repeat tests will be requested.
- Any other significant disease, disorder, or finding which may significantly increase
the risk to the volunteer because of participation in the study, affect the ability of
the volunteer to participate in the study or impair interpretation of the study data
- Inability of the study team to contact the volunteer's GP to confirm medical history
and safety to participate