1.
ClinicalTrials.gov; 08/02/2024; TrialID: NCT06255626
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06255626
ABSTRACT
Condition:
COVID-19Intervention:
Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)Primary outcome:
Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration;Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1Criteria:
Inclusion Criteria:
- Healthy volunteers Age =18 and <85
- Able to understand and comply with planned study procedures and sign an informed
consent before performance of any study-related screening procedures
- Who has received a primary series of vaccination and = 1 booster(s) of COVID-19 mRNA
vaccination(s) with the last boost at least 6 months prior to the inclusion in the
study
- Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline
phosphatase
- Normal haematology lab values
- Negative virology assessment
- Normal Urine testing
- Volunteers must meet the eligibility criteria in the approved package labelling of the
active comparator
- For women of childbearing potential: use of an effective contraceptive method and
negative pregnancy test. For male participants, use of an effective method of
contraception with their partner
Exclusion Criteria:
- Acute febrile infection within the previous 72 hours and/or presenting symptoms
suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days
- Immunosuppressive medications received within last three months before first IMP
administration or within 6 months for chemotherapies
- Immunoglobulins within 90 days before first IMP administration
- Blood products within 120 days before first IMP administration
- Any medical condition, such as cancer, that might impair the immune response
- Use of any experimental therapy
- Intent to participate in another study of an investigational research agent within 4
weeks prior to the enrolment visit or until the end of the study
- Currently pregnant or breastfeeding
- History of severe adverse events following vaccine administration
- Any bleeding disorder considered as a contraindication to an intramuscular injection
- A condition that requires active medical intervention or monitoring to avert grave
danger to Asthma other than mild, well-controlled asthma.
- Hypertension
- BMI = 40 kg/m2; = 18 kg/m2; or BMI = 35 kg/m2 with 2 or more of the following: age >
45, current smoker, known hyperlipidemia, blood pressure is defined as consistently =
140 mm Hg systolic and = 90 mm Hg diastolic
- Malignancy
- Asplenia
- Seizure disorder
- History of hereditary angioedema acquired angioedema, or idiopathic angioedema
- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with
permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring
medication, treatment, or clinical follow-up
- History of autoimmune disease
- Any medical, occupational, or other condition that, in the judgment of the
investigator, would interfere with or serve as a contraindication to protocol
adherence
- Psychiatric condition that precludes compliance with the protocol.
- Live attenuated vaccines received within 30 days before first IMP administration or
scheduled within 28 days after one of the last injection according to the protocol
- Vaccines that are not live attenuated vaccines and were received within 21 days prior
to first IMP administration
- Allergy treatment with antigen injections within 30 days before first IMP
administration and until the end of the study
2.
ClinicalTrials.gov; 29/08/2023; TrialID: NCT06022211
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06022211
ABSTRACT
Condition:
Post COVID-19 ConditionPrimary outcome:
The primary endpoint is the proportion of participants who present a post-COVID-19 condition in adult patients with confirmed mild, moderate, and severe COVID-19 in Hai Phong, Vietnam.Criteria:
Inclusion Criteria:
- Adults aged 18 years or more;
- With a history of documented COVID-19 as confirmed by either a positive SARS-CoV-2
RT-PCR or antigenic test, 3-12 months before inclusion;
- Hospitalised in Viet Tiep 2 hospital or Kien An hospital (tertiary care hospitals)
with moderate or severe COVID-19 or registered in provincial CDC health system for
mild COVID-19;
- Accepting to participate in the study;
Exclusion Criteria:
- Not able to understand or answer a quick phone questionnaire;
- Individuals who refuse or cannot come to Viet Tiep 2 hospital in case of the suspected
post-COVID-19 condition.
3.
ClinicalTrials.gov; 17/10/2022; TrialID: NCT05587894
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05587894
ABSTRACT
Condition:
COVID-19;ImmunodeficiencyIntervention:
Drug: Paxlovid 5 days;Drug: Paxlovid 10 days;Drug: VekluryPrimary outcome:
Percentage of patients with SARS-CoV-2 viral load (threshold cicle (Ct) <32) by real-time RT-PCR in nasopharyngeal swabs at Day 10 after treatment initiation.Criteria:
Inclusion Criteria:
1. Laboratory confirmed SARS-CoV-2 infection by RT-PCR
2. Asymptomatic or mild to moderate COVID-19 (WHO progression scale =5)
3. = 16 years of age;
4. Body weight > 40 kg
5. Immunocompromised as defined by = 1 risk factors for severe COVID-19 as assessed by
the FOPH list (criteria 5: diseases/treatments leading to immune suppression)
- Severe immunosuppression (e.g., HIV infection with CD4 + T cell count <200 / µl)
- Neutropenia (<1000 neutrophils / µl) =1 week
- Lymphocytopenia (<200 lymphocytes/µl)
- Hereditary immunodeficiencies
- Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long
time [an equivalent dose of prednisone >20 mg/day > 3 months], monoclonal
antibodies, cytostatics, biological products, etc.) in the last 12 months
- Aggressive lymphomas (all types)
- Acute lymphatic leukemia
- Acute myeloid leukemia
- Acute promyelocytic leukemia
- T prolymphocytic leukemia
- Primary central nervous system lymphoma
- Stem cell transplantation
- Light chain amyloidosis
- Chronic lymphoid leukemia
- Multiple myeloma
- Sickle cell disease
- Bone marrow transplant
- Organ transplant
- Being on the waiting list for an organ transplant
6. Willing and able to comply with study requirements and restrictions as described in
the informed consent form (ICF)
7. Enrolled in or a beneficiary of a Social Security program (State Medical Aid (AME) is
not a Social Security program)
8. Participant's or its legal representative's signature of the informed consent form
Exclusion Criteria:
1. SARS-CoV-2 PCR =30 CT at screening
2. Hypersensitivity to study drugs (active substance(s) or excipients)
3. Creatinine clearance <30ml/mn/.73m² (CKD-EPI)
4. AST or ALT > 5 times the upper limit
5. Is taking or is anticipated to require any prohibited therapies*
6. Participation in another interventional clinical study through Day 28 with an
investigational compound or device, including COVID-19 therapeutics
7. Presence of any condition for which, in the opinion of the investigator, participation
would not be in participant's best interest or that could prevent, limit, or confound
the protocol-specified assessments
8. Having received antiviral treatments against SARS-CoV-2 in the 14 days before the
inclusion
9. Pregnant or breastfeeding female
- Study SOPs based on recommendations from the Liverpool COVID-19 interactions,
French Society for Pharmacology and Therapeutics and French Speaking
Transplantation society will be provided to guide investigators
4.
ClinicalTrials.gov; 10/10/2022; TrialID: NCT05582239
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05582239
ABSTRACT
Condition:
Severe Acute Respiratory Infection (SARI);Influenza;COVID-19Primary outcome:
Vaccine effectivenessCriteria:
Inclusion Criteria:
- Age = 18 years old
- Admitted in a hospital for at least 24 h
- Presents SARI criteria within onset within the last 14 days before sampling and less
than 48 h after hospitalisations:
At least one of the following signs (without treatment): fever or feverishness, malaise,
headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness)
Associated with at least one respiratory symptom or sign (cough, sore throat or shortness
of breath; or tachypnoea or signs of low oxygen saturation)
- completed non-opposition form
- Respiratory samples within 14 days after symptoms onset, in the context of care
Exclusion Criteria:
- Contraindication of vaccination
5.
ClinicalTrials.gov; 01/04/2022; TrialID: NCT05409261
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05409261
ABSTRACT
Condition:
COVID-19;Vaccine Reaction;SARS CoV 2 Infection;Vaccine Adverse ReactionIntervention:
Biological: Ad26.COV2.S;Biological: NVX-CoV2373Primary outcome:
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) levelCriteria:
Inclusion Criteria:
- Age between 18 and 45 years old or 55 years and older
- Be eligible to receive one of the study vaccines as part of the trial
- Understand and agree to comply with study procedures (visits, telephone calls)
- Agree not to participate in any other vaccine study during the time of the study
- Give written informed consent prior to any examination performed as part of the trial
Exclusion Criteria:
- Positive SARS-CoV-2 antigenic test
- Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
- History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months
prior to inclusion
- Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body
temperature = 38.0°C)
- Pregnant or breastfeeding woman
- Known chronic disease impacting the participant's immune response (uncured cancer,
human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection)
- Anti-coagulant treatment
- Immunosuppressive treatment
- Contraindication to the proposed vaccine (according to RCP)
- Previously received at least one injection of a SARS-CoV-2 vaccine
- Patient having received immunoglobulin or another blood product within 3 months prior
to inclusion
- A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms
such as rash, breathing difficulties, laryngeal edema, or a history of allergic
reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
- Any condition that, in the opinion of the investigator, may adversely affect the
well-being of the participant and interfere with the purpose of the study
6.
ClinicalTrials.gov; 28/03/2022; TrialID: NCT05409300
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05409300
ABSTRACT
Condition:
COVID-19;Vaccine Adverse Reaction;Sars-CoV-2 Infection;Healthy VolunteerIntervention:
Biological: BBIBP-CorVPrimary outcome:
Anti-SARS-CoV-2 Spike IgG levelCriteria:
Inclusion Criteria:
- Age between 18 and 45 years old or 55 years and older
- Be eligible to receive one of the study vaccines as part of the trial
- Understand and agree to comply with study procedures (visits, telephone calls)
- Agree not to participate in any other vaccine study during the time of the study
- Give written informed consent prior to any examination performed as part of the trial
Exclusion Criteria:
- Age between 46 and 54 years old
- Positive SARS-CoV-2 antigenic test
- Positive SARS-CoV-2 PCR results less than 48 hours old
- History of infection by COVID-19 confirmed within 3 months prior to inclusion
- Symptoms compatible with COVID-19: sick or febrile participants (body temperature =
38.0°C)
- Pregnant or breastfeeding woman
- Known chronic disease impacting the participant's immune response (uncured cancer,
human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection)
- Anti-coagulant treatment
- Immunosuppressive treatment
- Contraindication to the proposed vaccine (according to RCP)
- Patient having received immunoglobulin or another blood product within 3 months prior
to inclusion
- Previously received at least one injection of a SARS-CoV-2 vaccine
- A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms
such as rash, breathing difficulties, laryngeal edema, or a history of allergic
reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
- Any condition that, in the opinion of the investigator, may adversely affect the
well-being of the participant and interfere with the purpose of the study
7.
ClinicalTrials.gov; 23/03/2022; TrialID: NCT05311891
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05311891
ABSTRACT
Condition:
COVID-19Intervention:
Diagnostic Test: RT PCRPrimary outcome:
Number of SARS-CoV-2 sequences generated partially and in whole genomeCriteria:
Inclusion Criteria:
- Major subject (cf. country)
- Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
- Not objecting to participating in the research
Exclusion Criteria:
- NA
8.
ClinicalTrials.gov; 08/03/2022; TrialID: NCT05311865
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05311865
ABSTRACT
Condition:
Healthy ParticipantIntervention:
Other: Club eventPrimary outcome:
Number of positive RT-PCR at day 7Criteria:
Inclusion Criteria:
- Aged between 18 and 49 years old
- Vaccination completed
- People who declared to have no risk factor to severe form for Covid-19 disease
- People who declared not to live in the same place as someone with these risk factors
- People residing in Ile-de-France area
- People affiliated with the the French social security citizen scheme
Exclusion criteria:
- Presence of symptoms of COVID in the 2 weeks before the event
- Pregnant woman or woman who declares not having an effective contraception method
- Self identification of medical conditions or comorbidities identified as a proven risk
of severe COVID infection
- People living with a person with these risk factors
- Confirmed diagnosis of SARS-CoV-2 within two weeks before the event
- Participants under tutorship or curatorship;
- Underage participants;
- Participants unable to give free and informed consent;
- Participants not affiliated to the French social security citizen scheme: obligation
to join a social security scheme or be a beneficiary thereof.
- Participants under legal protection
9.
ClinicalTrials.gov; 25/01/2022; TrialID: NCT05216588
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05216588
ABSTRACT
Condition:
COVID-19;Immunocompromised HostPrimary outcome:
Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activityCriteria:
Inclusion Criteria:
- Adults (18 years-old or more)
- Patient who received the first administration of Evusheld at 300 mg for less than 4
months and should receive a second dose, according to French recommendations OR
Patient scheduled to receive or having received less than a month ago an injection of
anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg,
according to the French SARS-CoV-2 RT recommendations
- qPCR negative at baseline
- SARS-CoV-2 RT-qPCR Negative at inclusion
- Patients who remain seronegative after a complete COVID-19 vaccination schedule
- Immunocompromised patients :
Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient :
kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor
- Life expectancy > 3 months
- Social security affiliation
- Lack of a legal protection measure
- Signed informed consent
Exclusion Criteria:
- Participation to another clinical study
- State medical aid
- Ongoing or scheduled plasmapheresis or immunoadsorption
- Pregnant / lactating woman
- Patient whose isolation period is underway following contact with a confirmed case of
SARS-CoV2 infection
- Hypersensitivity to one of the active substances or to one of the excipients
10.
ClinicalTrials.gov; 03/01/2022; TrialID: NCT05300035
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05300035
ABSTRACT
Condition:
HIV/AIDS and InfectionsIntervention:
Drug: Recombinant human monoclonal antibody (bNAbs);Drug: PlaceboPrimary outcome:
Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART.Criteria:
Inclusion Criteria:
- Confirmed primary HIV-1 infection diagnostic
- Aged =18 to =70 years old at screening
- Willing to use use an effective method of contraception from the inclusion until the
end of the follow-up in the trial
- Negative plasmatic beta human chorionic gonadotropin (ß-HCG) pregnancy test, when
applicable
- Agree not to seek pregnancy including through alternative methods, such as artificial
insemination or in vitro fertilization until after the last required protocol clinic
visit, when applicable
- Informed and written signed consent
- Participant with regular health insurance
- Willing to accept the trial constraints (travel for IMP administration and ART
interruption)
- Willing to be vaccinated against COVID-19 according to recommandations
Exclusion Criteria:
- Participation in any other clinical trial requiring additional blood sampling
Participation in an observational study without additional blood sampling is permitted
- Participants in whom condom use or PrEP use by the partner will be difficult or
impossible
- Pregnant or breastfeeding patient
- Participants under guardianship or curatorship
- Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosis
active infection History of ischemic heart disease (myocardial infarction, stable or
unstable angina, stroke)
- Current or past history of cancer, excluding squamous cell skin cancers
- History or acute known inflammatory ophthalmic affection (uveitis, choroiditis, optic
neuropathy)
- Any medical condition that contraindicates ART interruption
- Concomitant or previous conditions that preclude injection of monoclonal antibodies
- History of systemic corticosteroids, immunosuppressive and anti-cancer medications
within the last 6 months
- History of severe reaction to a vaccine or drug infusion or history of severe allergic
reactions
- Individuals with any contraindication (including hypersensitivity reaction) to
3BNC117-LS and 10-1074-LS infusion
- Prothrombin < 50%
- Creatinine clearance < 60mL/mn (Cockroft)
- ASAT or ALAT or bilirubine (total et conjugated) = 10 times the upper limit of normal
- Patient with an isolated HIV-2 viral strain
- Planned absence that could affect participation in the trial (travel abroad,
relocation, impending transfer...)
11.
ClinicalTrials.gov; 23/12/2021; TrialID: NCT05230368
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05230368
ABSTRACT
Condition:
HIV-1-infection, Subtype bIntervention:
Drug: Decitabine cycle 1;Drug: Romidepsin cycle 1;Drug: Decitabine cycle 2;Drug: Romidepsin cycle 2;Drug: Decitabine cycle 3;Drug: Romidepsin cycle 3;Drug: Decitabine cycle 4;Drug: Romidepsin cycle 4Primary outcome:
Incidence of Serious Adverse Events (SAE) and severe clinical or biological adverse events (AE) related to the study drugsCriteria:
Inclusion Criteria:
- Man aged 18-69 years;
- Man with documented infection with sub-type B HIV-1;
- On cART since more than 48 months before pre- screening and at a stable regimen for at
least 2 months 27 before pre-screening and until inclusion;
- HIV plasma viral load persistently < the threshold (of the local test used) and
undetectable during the 12 months prior to pre-screening and until inclusion, with no
blip* allowed (a minimum of 2 VL results are necessary, including the pre-screening
value). * blip is defined as 50cp =HIV viral load<400 cp mL-1;
- CD4+ T-cells count nadir = 200 cells per mm3 documented in the medical file; Transient
CD4+ T-cells count < 200 cells per mm3 is allowed for a short period if the value is
associated with a single isolated acute infection
- CD4+ T-cells count = 500 cells per mm3 for at least 12 months before pre-screening and
until inclusion;
- EBV viral load < 1000 cp.mL-1, CMV viral load < 10000 cp mL-1;
- Complete COVID-19 vaccine scheme (according to national recommendations).
- Able and willing to comply with study visits and procedures as per protocol;
- Able to understand, sign and date the written voluntary informed consent form at the
pre screening visit prior to any protocol-specific procedures.
Regulatory criteria (French regulations):
- Free, informed and written consent signed by the person and the investigator (at the
latest on the day of pre-screening and before any investigation carried out as part of
the trial) (Article L1122-1-1 of the Code of Public Health).
- An affiliated person beneficiary of a social security scheme (Article L1121-11 of the
Public Health Code) (Aide Médicale d'Etat or AME is not a social security scheme).
- A person who agrees to be registered in the national file of persons who lend
themselves to biomedical research (article L1121-16 of the Public Health Code).
Regulatory criteria (Belgian regulations):
- Free, informed and written consent signed by the person and the investigator (at the
latest on the day of pre-screening and before any investigation carried out as part of the
trial) (law of 7 May 2004. article 6)
Exclusion Criteria:
- Man who want to father a child or refuse contraception (condoms) while receiving
treatment and for 3 months following completion of treatment; Man with a female
partner of childbearing potential who refuses to use a highly effective contraceptive
method during the same period (Experimental treatment period and for 3 months
following completion of experimental treatment).
- Clinically significant cardiac disease including QTc-prolongation (QTc value >
450msec);
- On PI based regimen or regimen containing NNRTI (except Doravirine which is allowed),
Ritonavir or Cobicistat;
- Treated with CYP 450 inducer or inhibitor, in particular dexamethasone, carbamazepine,
phenytoin, rifabutin, rifapentine and phenobarbital;
- Treated with anti-arrhythmic medicines or medicinal products that lead to significant
QT prolongation;
- Treated with warfarin or coumarin derivative;
- History of an AIDS-defining clinical illness (based on CDC classification, appendix
A4);
- Coinfection with viral hepatitis B;
- Coinfection with viral hepatitis C;
- Active malignancy that may require chemotherapy or radiation therapy;
- Any significant acute medical illness in the 8 weeks prior to pre-screening and until
inclusion;
- Haematological or biochemical laboratory parameters at pre-screening and screening :
Hemoglobin (
Partial Thromboplastin Time (>ULN); grade = 2 for the following parameters: Total
serum Creatinine, urea, uric acid, glycemia, total serum bilirubin, Alkaline
Phosphatase (ALP) AST-ALT, gammaglutamyl transferase (GGT), lipasemia, LDH, Ionogram:
Na, K, Ca, Mg, CRP, albumin, proteins, CPK;
- Liver insufficiency (Child Pugh score >5);
- Kidney insufficiency (Estimation of glomerular filtration<60mL/mn/1,73m2 ; evaluation
with CKDepi formula, according to the 2012 French Haute autorité de santé
recommandations);
- Participant under guardianship or curatorship or deprived of their liberty by a
judicial or administrative decision
- Participant potentially inable to follow the protocol requirements (e.g. comprehension
of the study requirements, ability to understand and comply with procedures for
collection of safety data, expressed availability for the required study period, and
ability and willingness to attend scheduled visits).
- Participating to another interventional study or still in an exclusion period from
another clinical trial (category 1 or 2 study for France);
- Planning to participate in a study within 3 months after the end of the present trial.
12.
ClinicalTrials.gov; 01/09/2021; TrialID: NCT05033210
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05033210
13.
ClinicalTrials.gov; 05/05/2021; TrialID: NCT04885452
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04885452
ABSTRACT
Condition:
SARS-CoV Infection;Covid19Intervention:
Other: biobankPrimary outcome:
Percentage of patients hospitalized (if the patient was outpatient) or whose hospitalization was extended for complications from COVID-19 within 1 month of symtoms' onset.Criteria:
Inclusion Criteria:
- Adults with the criteria for COVID-19 treatment within the French compassionate
program (ATU/AAP)
- Adults covered by the French social health coverage
- Adults who signed the informed consent form
Exclusion Criteria:
- Exclusion criteria described in the French compassionate program (ATU/AAP)
- Patient participating in another biomedical research with an exclusion period ongoing
at inclusion
- Vulnerable patient (adults legally protected: under judicial protection, guardianship,
or supervision, persons deprived of their liberty)
- Pregnant or breastfeeding woman
14.
ClinicalTrials.gov; 04/05/2021; TrialID: NCT04920838
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04920838
ABSTRACT
Condition:
Covid19;Covid19 Drug Treatment;Severe Acute Respiratory Syndrome Coronavirus 2;SARS-CoV2 InfectionIntervention:
Drug: Nitazoxanide and Ciclésonide;Drug: Telmisartan 20Mg Oral Tablet;Drug: Paracetamol;Drug: Fluoxétine and BudésonidePrimary outcome:
SpO2 = 93% within 14 days;Death within 14 daysCriteria:
Inclusion Criteria:
- Adults 18 years of age at the time of screening or >= 40 years and presenting at least
one comorbidity : high blood pressure; a known obesity and/ or a known and treated
diabete.
- SARS-CoV-2 infection confirmed by molecular biology (RT-PCR on a nasopharyngeal or
oropharyngeal swab) or by antigen test validated in the country according to national
guidelines
- A viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen
saturation level (SpO2) >=94%.
- Mild Covid-19 symptoms with an onset < 7 days before inclusion.
- Signed written consent from the patient or his/her representative.
- No need an oxygen therapy according to international guidelines (WHO Progression
Scale, grade 2 to 4)
- Accepting and having the ability to be reached by telephone throughout the study.
- Having designated a contact person who can be contacted in case of emergency.
- Accepted to be reached by phone along throughout the study
Exclusion Criteria:
- Blood oxygen saturation level (SpO2) < 94%.
- Known hypersensitivity to investigational products
- Chronic treatment with inhaled corticosteroids (up to 30 days)
- Known history of renal or hepatic failure
- Abnormal physical examination findings:
- respiratory rate < 25 per minute;
- Clinical hypotension with associated signs justifying hospital care
- Feeling unwell for more than 7 days prior to screening.
- End-organ compromise requiring admission to a resuscitation or continuous care unit or
short-term life-threatening comorbidity with life expectancy < 3 months.
- For any new antiviral included in the study, prior treatment with the antiviral,
presence of contraindication to its use or intake of concomitant medication proscribed
with its use.
- Patients with known suicidal thoughts, severe psychiatric disorders or major
depression that is uncontrolled or controlled by one of the prohibited drugs
- Known history of long QT syndrome or severe ventricular cardiac arrhythmia
(ventricular tachycardia, patients with recovered ventricular fibrillation)
- Unwilling or unable to comply with the requirements of the study protocol at any time
during the study, e.g. no access to or not comfortable with use of a smartphone or
with answering questions using a telephone, in the opinion of the Investigator or
cannot use an inhalation chamber.
- Any other reason that makes it impossible to monitor the patient during the study.
- Enrolled in other clinical trials with unregistered drugs or with registered drugs
that may interact with any of the study IPs or are contraindicated as concomitant
therapy within the last 3 months prior to screening
15.
ClinicalTrials.gov; 16/04/2021; TrialID: NCT04868942
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04868942
ABSTRACT
Condition:
Corona Virus InfectionIntervention:
Other: Assisting to the eventPrimary outcome:
SARS-CoV-2 conversion ratesCriteria:
Inclusion Criteria:
- Student at Aix Marseille University
- who has declared that he or she does not carry any risk factor for severe forms of the
disease (HCSP criteria of 29/10/2020)
- who has declared that he or she does not live under the same roof as a person who does
carry such factors, and committed to strictly following the study's health protocol,
- carrying a smartphone which is registered on the "TousAntiCovid" application (with
Bluetooth activation), and agreeing to install the Maela application on the smartphone
for remote medical monitoring.
Exclusion Criteria:
- Volunteer with clinical signs of acute respiratory infectious disease
- Volunteer living with a person with clinical signs of acute respiratory infectious
disease
- Volunteer with a risk factor for severe COVID-19
- Volunteer who had a COVID-19 infection in the 3 months prior to the study
- Volunteer who are not affiliated to the social security system
- Volunteer vaccinated against COVID-19
- Pregnant women and people living with pregnant women
- Persons deprived of liberty
- Adult with legal protection
- Volunteer unable to comply with protective measures, at the concert or at home
- Volunteer participating in another clinical research study
16.
ClinicalTrials.gov; 08/04/2021; TrialID: NCT04863547
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04863547
ABSTRACT
Condition:
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Intervention:
Other: Data collectionPrimary outcome:
To estimate the proportion of Severe disease form;To estimate the proportion of Mortality;To estimate the proportion of WHO score > 5;To estimate the proportion of Patient who received critical care;To estimate the proportion of patients who had invasive ventilation;To estimate the proportion of patients who had high flow oxygen therapy;Time between the first day of symptoms and the first day of hospitalization;Delay between the first day of symptoms and the first day of hospitalization;Time between the first day of symptoms and the severity of disease;Time between the first day of symptoms and mortalityCriteria:
Inclusion Criteria:
- Adult
- Acute symptomatic PCR + COVID with screening
- Hospitalized for acute COVID between 01/01/2021 (or since the setting up of the
screening in the center) and 02/28/2021
Exclusion Criteria:
- Opposition to participation
- Identification of variants other than 20I / 501Y.V1
- Patients infected with SARS-CoV-2 in a nosocomial context
17.
ClinicalTrials.gov; 25/03/2021; TrialID: NCT04824651
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04824651
ABSTRACT
Condition:
Immune DeficiencyIntervention:
Biological: COVID-19 vaccinePrimary outcome:
Humoral immunity to Covid-19 vaccination using 2 serological criteria:;Humoral immunity to Covid-19 vaccination using 2 serological criteria:;Humoral immunity to Covid-19 vaccination using 2 serological criteria:;Humoral immunity to Covid-19 vaccination using 2 serological criteria:;Humoral immunity to Covid-19 vaccination using 2 serological criteria:;Humoral immunity to Covid-19 vaccination using 2 serological criteria:;Percentage of participants seroconverting for Anti Nucleoprotein antibodies;Percentage of participants seroconverting for Anti Nucleoprotein antibodies;Percentage of participants seroconverting for Anti Nucleoprotein antibodies;Percentage of participants seroconverting for Anti Nucleoprotein antibodies;Percentage of participants seroconverting for Anti Nucleoprotein antibodies;Percentage of participants seroconverting for Anti Nucleoprotein antibodies;Seroconversion or increase of factor 2 titer of antibodies anti-Spike/anti-RBD between the second and the third dose for the participants with 3 injectionsCriteria:
INCLUSION CRITERIA :
General inclusion criteria for all patients of all groups
- Be 18 years or older
- Get vaccinated against Covid-19 as part of the national vaccination campaign
- Accept the conditions of participation corresponding to each sub-population
- Commit to respecting the schedule of visits provided in the research protocol
- Plan to reside in France for at least 2.5 years from inclusion date
- Give their free, informed and written consent (at the latest on the day of inclusion
and before any examination / samples) by signing the consent form
- Be a member of or beneficiary of a social security scheme (State Medical Aid is not a
social security scheme).
General inclusion criteria for patients with a chronic condition of interest
• Present at least one pathology listed in the part listed above
Inclusion criteria specific to Solid Organ Transplantation
- Not presenting intercurrent infections (cholangitis...)
- No prior anaphylaxis and cellular or humoral rejection within 3 months
- Having more than 3 months of remission after treatment with Thymoglobulin or Rituximab
Inclusion criteria for control subjects • Be free from the chronic conditions of interest
listed in the context section or other chronic conditions/treatment that may affect the
immune response
Inclusion criteria for control subjects free from chronic conditions of interest and with
first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm
vaccine BNT162b2
• Be vaccinated with a first injection with Astra-Zeneca vaccine AZD1222 and a second
injection with Pfizer ARNm vaccine BNT162b2
NON INCLUSION CRITERIA :
General non inclusion Criteria for all participants of all groups
- Be under protective supervision (guardian or curatorship)
- Being a pregnant or breastfeeding woman
- Present a contraindication to Covid-19 vaccination : Have a known or suspected allergy
to any component of the vaccine, Have had at-risk contact with a confirmed Covid-19
person in the last 7 days, Have presented clinical signs suggestive of Covid-19 in the
last 7 days, Have an acute febrile episode on inclusion / vaccination, Have received a
vaccine in the last 15 days ...
- Have had a documented Covid-19 Infection (PCR or antigenic test)
- Refuse that their Social Security number is collected for accessing the National
Health Data System (NSDS)/Data Health Hub national health databases
- For safety reasons, must agree to not enter in a vaccine clinical trial during the
entire period of inclusion and follow-up of the research
Specific non inclusion criteria for PLWHIV
- Being infected with HIV-2
- Presenting another cause for immunosuppression (undergoing immunosuppressive
treatment, biotherapy)
- Presenting a non controlled opportunistic infection
Specific non-inclusion for control subjects
- Have one or more of the chronic conditions of interest listed above or affected by any
other pathology or treatment that may affect the immune response
(autoimmune/inflammatory pathology or immune deficiency not listed above, liver
failure, immunosuppressive therapy (like oral corticosteroids at >= 10 mg/d Prednisone
equivalent for more than 15 days) or radiotherapy within 6 months prior to inclusion
or planned for the duration of the study)
- Life expectancy of less than 2 years
18.
ClinicalTrials.gov; 24/03/2021; TrialID: NCT04844775
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04844775
ABSTRACT
Condition:
Healthy AdultsIntervention:
Biological: Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L;Biological: DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above);Biological: DNA-HIV-PT123 4mg and CN54gp140/MPLA-LPrimary outcome:
Part 1- Dose Escalation- Any adverse reaction that results in a clinical decision to stop immunisations;Part 2- Randomised Comparison - Any adverse reaction that results in a clinical decision to stop immunisations;PART 2 Randomised comparison- Total IgG Binding antibody response rateCriteria:
Inclusion Criteria:
1. Healthy adults aged 18- 55 years on the day of screening
2. BMI between 18-30 kg/m2 (inclusive)
3. Unlikely to acquire HIV during follow-up
4. Willing and able to provide written informed consent
5. If female and of childbearing potential* age and not sterilised, willing to use a
highly effective method of contraception from screening until 12 weeks after last
injection
6. If male and not sterilised, willing to avoid impregnating female partners from
screening until 12 weeks after last injection**
7. Willing to avoid all other vaccines from 28 days before the first injection through to
28 days after subsequent study injections
8. Willing and able to comply with visit schedule and provide blood samples
9. Being covered by medical insurance or in National Healthcare System
- A woman will be considered of childbearing potential following menarche and until
becoming post-menopausal unless permanently sterile. Permanent sterilisation
methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- It is recommended that participants have an up to date vaccination status
for any required immunisations including authorised COVID-19 vaccines
Exclusion Criteria:
1. Pregnant or lactating
2. Has a significant clinical history, physical finding on clinical examination during
screening, or presence of a disease that is active or requires treatment to control
it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver,
neurological, oncological, psychiatric, immunosuppresive/immunodeficient or other
disorders which in the opinion of the investigator is not compatible with healthy
status, may compromise the volunteer's safety, preclude vaccination or compromise
interpretation of the immune response to vaccine. Individuals with mild/moderate,
well-controlled comorbidities are allowed.
3. HIV 1 or 2 infection or indeterminate test at screening
4. History of anaphylaxis or angioedema
5. History of severe or multiple allergies to drugs or pharmaceutical agents
6. Known hypersensitivity to any component of the vaccine formulation used in this trial
7. History of severe local or general reaction to vaccination defined as
1. local: extensive, indurated redness and swelling involving most of the arm, not
resolving within 72 hours
2. general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
oedema; collapse; convulsions or encephalopathy within 72 hours
8. Receipt of any experimental vaccine within 5 years from screening.
9. Receipt of blood products or immunoglobulins within 18 weeks of screening.
10. Receipt any of immunosuppressive agents within 18 weeks of screening by any route
other than skin and intranasal.
11. Detection of antibodies to hepatitis B & C
12. Participating in another clinical trial with an investigational drug or device, or
treated with an investigational drug within 28 days of screening
13. Any of the values that are confirmed on repeat testing as defined in protocol
19.
ClinicalTrials.gov; 07/03/2021; TrialID: NCT04824638
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04824638
ABSTRACT
Condition:
Healthy;Immunization; InfectionIntervention:
Biological: 3 doses of BNT162b2 vaccine;Biological: 2 dose of BNT162b2 vaccinePrimary outcome:
IgG humoral response to vaccine 28 days post vaccinationCriteria:
Inclusion Criteria:
1. 18 to 45 years old or at least 65 years old,
2. Healthy adults or stable medical condition for adults with pre-existing medical
conditions. A stable medical condition is defined as disease not requiring significant
change in therapy or hospitalization for worsening disease during 3 months before
enrolment, nor expected to require any significant change in therapy or
hospitalization for worsening disease in foreseeable future.
3. Group 1: Healthy adults with no previous history of SARS COV2 infection (PCR-,
antigenic test- or chest TDM- or serology SARS-CoV-2-) Group 2: Healthy adults with
history of infection with SARS COV 2 (PCR+, antigenic test+ or chest TDM+ or serology
SARS-CoV-2 of more than 5 months) OR have been a household contact subject and have
presented COVID-19 symptoms [Experienced at least TWO of the following systemic
symptoms: Fever (= 38ºC), chills, myalgia, headache, sorethroat, new olfactory and
taste disorder(s), gastrointestinal symptoms (diarrhea and/or vomiting) or at least
ONE of the following respiratory signs/symptoms: cough, shortness of breath or
difficulty breathing, OR clinical or radiographical evidence of pneumonia] since at
least 5 months ago and have had a positive SARS-CoV-2 serology between this episode
and pre-inclusion.
4. A female participant is eligible to participate if she is not pregnant or
breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential,
a female must be post-menopausal for at least 1 year or surgically sterile. OR
- Is of childbearing potential and agrees to use an effective contraceptive method
from at least 4 weeks prior to vaccination until at least 4 weeks after the last
vaccination. A participant of childbearing potential must have a negative blood
pregnancy test at enrolment visit.
5. Understands and agrees to comply with the study procedures (visits, phone calls) based
on Investigator judgement
6. Written and informed consent signed by the person and the investigator (no later than
the day of pre-inclusion and prior to any examination realized in the frame of the
trial) (article L1122-1-1 of the Public Health Code)
7. Affiliated or beneficiary of a social security scheme (article L1121-11 of the Public
Health Code) (AME is not a social security scheme)
8. who agrees to be registered in the national file of persons who lend themselves to
biomedical research (article L1121-16 of the Public Health Code).
Exclusion Criteria:
1. Participant is ill or febrile (body temperature = 38.0°C) within 72 prior hours or
and/or symptoms suggestive of COVID-19 or being contact subject within the past 14
days at enrolment visit.
(Ill or febrile participants may be re-scheduled within the trial inclusion period
when no longer presenting symptoms, except if condition is COVID19)
2. Participants with positive PCR, antigenic test or chest TDM or serology to SARS-CoV-2
at the enrolment visit, only for the group1.
3. Participants who already received another anti-SARS-CoV-2-vaccine
4. Participants who received BCG given within the last year.
5. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent
prednisone /day (excluding topical preparations and inhalers) within 3 months prior to
enrolment or 6 months for chemotherapies
6. Received immunoglobulin or other blood product within 3 months prior to enrolment or
planned receipt of immunoglobulin or a blood product through study completion.
7. Received any vaccination within 4 weeks prior to first injection or plan to receive a
licensed vaccine within 4 weeks after the last injection.
8. History of severe adverse reactions to vaccine administration, including anaphylaxis
and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and
abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated
by any component of the anti-SARS-CoV-2-vaccine.
9. History of severe allergic event
10. Known HIV, active HCV or HBV infection
11. Any pathological condition, such as cancer, which may be susceptible of reducing
immunity response
12. Any bleeding disorder considered as contraindication to intramuscular injection or
phlebotomy
13. The use of investigational Ig, investigational monoclonal antibodies or convalescent
serum are not allowed during the study
14. Any condition which in the opinion of the investigator may interfere with the aim of
the study
15. Pregnant or breastfeeding or positive pregnancy blood test at enrolment visit.
16. An immediate family member or household member of study staff.
17. Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4
weeks before the enrolment visit or still in an exclusion period from another clinical
trial or participation in another investigational clinical study planned before the
study completion.
18. People under legal protection measure (tutorship, curatorship or safeguard measures)
20.
ClinicalTrials.gov; 14/12/2020; TrialID: NCT04716543
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04716543
ABSTRACT
Condition:
Influenza -Like Illness;Covid19Intervention:
Diagnostic Test: ILI and COVID-19 detectionPrimary outcome:
Prevalence of SARS-CoV-2 RNA in respiratory samples collected from influenza-like illness patients from cohort study 2020-2021Criteria:
All permanent residents of the household who meet the inclusion criteria of > 6 months old
and living in their respective village for at least 6 months will be eligible to
participate. All people from the anterior LACORIS study (2015-2019), will be invited to
participate to the study.
Over a year, active case finding for influenza-like illness (ILI) will be conducted among
the cohort by staff at CILM. The suspected ILI cases will be first identified using the WHO
clinical case definition of ILI and Covid 19 as either with:
Acute onset of fever (> 37.5°C axillary temperature or > 38°C tympanic temperature) AND
cough; OR Acute onset of ANY ONE OR MORE of the following signs or symptoms: Fever, cough,
general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anosmia (loss
of smell) or ageusia (loss of taste).
with symptoms with onset within the last 10 days.
Inclusion Criteria:
- Living in their respective village for 6 months or more.
- Physically reside in the village for more than 80% of the time during the duration of
the study.
- Study subjects = 6 months of age (no upper age limit).
- Consent form signed by patient, or if under 18 years of age or patients with learning
difficulty or other vulnerability with impaired ability to decide on consent, signed
by parent or guardian.
- Agrees to comply with study requirements.
Exclusion Criteria:
- Study subjects under the age of 6 months.
- Study subjects or parents/guardians that do not accept participation.
- Study subjects or parents/guardians who refuse to sign informed consent.