1.
ClinicalTrials.gov; 19/02/2024; TrialID: NCT06267300
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06267300
ABSTRACT
Condition:
Post-COVID-19 Syndrome;Post-COVID Syndrome;Post COVID-19 Condition;Post-COVID Condition;Post COVID-19 Condition, Unspecified;Long COVID;Long Covid19Intervention:
Drug: Hyperbaric oxygenPrimary outcome:
Physical and mental component scores of the 36-item Short Form Survey (SF-36)Criteria:
Inclusion Criteria:
- Cognitive and/or physical symptoms = 12 months after acute COVID-19 infection
- Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by
questionnaires and/or NASA LEAN test
- Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical
functioning' score of = 50 at baseline).
- Current treatment regimen is stable for at least 1 months before inclusion
Exclusion Criteria:
- Unfit for hyperbaric treatment
- Previous diagnosis of ME/CFS
- Unable to provide informed consent
2.
ClinicalTrials.gov; 20/04/2023; TrialID: NCT05831839
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05831839
ABSTRACT
Condition:
COVID-19;Cognitive Impairment;Cognition Disorder;Memory Disorders;Attention Deficit;Memory Impairment;Memory Loss;Attention ImpairedIntervention:
Device: RehaComPrimary outcome:
General cognition;Attention;Working memoryCriteria:
Inclusion Criteria:
- aged 18 years and older;
- patient has sufficient knowledge of Dutch language;
- CFQ> 43 at 2 year follow-up of CO-FLOW, indicating persistent cognitive complaints;
- Computer and internet-access.
Exclusion Criteria:
- A potential participant who meets any of the following criteria will be excluded from
participation in this study:
- Incapacitated patients like patients diagnosed with dementia;
- Patients should not be involved in concurrent rehabilitation program, cognitive
behavioural therapy or psychotherapy targeting cognition, anxiety and/or
depression.
3.
ClinicalTrials.gov; 26/10/2022; TrialID: NCT05600127
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05600127
ABSTRACT
Condition:
Urothelial CarcinomaIntervention:
Drug: AvelumabPrimary outcome:
Pathological complete response rateCriteria:
Inclusion Criteria:
1. Age = 18 years.
2. Have histologically confirmed urothelial carcinoma of the bladder, upper urinary tract
or urethra; a maximum of 50% of aberrant histology is allowed.
3. Have clinical stage cT4NxM0 or cTxN1-N3M0 as assessed by bimanual examination under
anaesthesia, CT scan, MRI scan or PET-CT scan.
4. Have at least stable disease after a minimum of 3 or a maximum of 4 cycles of
induction chemotherapy with cisplatin / carboplatin + gemcitabine according to RECIST
v1.1.
5. Are fit and willing to undergo radical surgery with removal of lymph node template
including all affected lymph nodes and the primary tumor.
6. World Health Organisation performance status of 0-2.
7. Provide written informed consent.
8. Negative pregnancy test in women with childbearing potential.
9. Adequate bone marrow function, including:
1. Absolute neutrophil count (ANC) =1,500/mm3 or 1.5 x 109/L;
2. Platelets =100 x 109/L;
3. Hemoglobin =5.6 mmol/L (may have been transfused).
10. Adequate renal function, defined as estimated creatinine clearance =30 mL/min as
calculated by the CKD-EPI eGFR.
11. Adequate liver function, including:
1. Total serum bilirubin <1.5 x upper limit of normal (ULN);
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x ULN.
Exclusion Criteria:
1. Predominant (>50%) non-urothelial carcinoma histology in the diagnostic endoresection
specimen of the bladder, urethra or upper urinary tract.
2. Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or
chronic infection.
3. Have an estimated creatinin clearance as assessed by the CKD-EPI eGFR of <30 ml/min.
4. Prior exposure to immune-mediated therapy with exclusion of Bacillus-Calmette Guérin
intravesical instillations, including but not limited to other anti-CTLA-4, anti PD-1,
anti PD-L1, or anti-PD-L2 antibodies.
5. Persisting toxicity related to prior chemotherapy (Grade >2 NCI CTCAE v5.0).
6. A diagnosis of any other malignancy within 2 years prior to inclusion, except for
adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the
breast or of the cervix, low grade prostate cancer on surveillance without any plans
for treatment intervention, or prostate cancer that has been adequately treated with
prostatectomy or radiotherapy and currently with no evidence of disease.
7. =2 cycles of induction platinum-based chemotherapy received.
8. Progression of disease during or following induction platinum-based chemotherapy, as
assessed by RECIST v1.1.
9. Distant metastatic disease.
10. Previous pelvic radiation therapy.
11. Breastfeeding women.
12. Bilateral upper urinary tract urothelial carcinoma.
13. Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid
disease not requiring immunosuppressive treatment are eligible.
14. Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
15. Active infection requiring systemic therapy.
16. Known severe hypersensitivity reactions to monoclonal antibodies (Grade 3), any
history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of asthma
symptom control per the Global Initiative for Asthma 2015).
17. Known prior or suspected hypersensitivity to avelumab.
18. Current use of immunosuppressive medication, EXCEPT the following:
1. Intranasal, inhaled, topical steroids, or local steroid injections (eg,
intra-articular injection);
2. Systemic corticosteroids at (equivalent) doses of maximum 10 mg prednisone;
3. Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication).
19. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive
therapy, or known human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS)-related illness.
20. Vaccination within 4 weeks of the first dose of study treatment and while on trial is
prohibited except for administration of inactivate vaccines (for example, inactivated
influenza vaccines) or mRNA vaccines (for example, COVID-19 vaccines).
21. Other severe acute or chronic medical conditions including colitis, inflammatory bowel
disease, and pneumonitis; psychiatric condition including recent (within the past
year) or active suicidal ideation or behaviour; or laboratory abnormality that may
increase the risk associated with study participation or study treatment
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the patient inappropriate for entry into this
study.
4.
ClinicalTrials.gov; 17/07/2022; TrialID: NCT05471440
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05471440
ABSTRACT
Condition:
Covid-19 VaccinationIntervention:
Drug: Direct boost mRNA;Drug: Direct boost adeno;Drug: Post-poned boost mRNA;Drug: Post-poned boost adenoPrimary outcome:
Is there an increase in antibody levels between day of boost and 28 days after boosting HCW that were initially primed with either the Janssen or an mRNA-based vaccine?;Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?Criteria:
Inclusion Criteria:
1. Participant is willing and able to give written informed consent for participation in
the trial.
2. Adult (male/female) between 18 and 65 years old
3. Sufficient level of the Dutch language to undertake all study requirements
Exclusion Criteria:
1. Adults younger than 18 or older than 65 years.
2. Adults primed with another vaccine than Janssen, Moderna or Pfizer.
3. History of allergic reactions likely to be exacerbated by any component of study
vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed
ingredients of the Janssen/Pfizer/Moderna vaccine).
4. Adults that are pregnant.
5. Currently being treated for cancer.
6. Severe kidney failure or dialyses dependent.
7. Status after organ-, stem cell- or bone marrow transplantation.
8. Use of immunosuppressant's.
9. Epilepsy.
10. HIV.
11. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or
prior history of significant bleeding of bruising following IM injections of vene
puncture.
12. Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral
anticoagulants (i.e. apixaban, dabigatran etc).
13. Participants who are currently participating in another research trial.
14. All regular contra-indications of the vaccines will be applied.
5.
ClinicalTrials.gov; 22/03/2022; TrialID: NCT05293483
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05293483
ABSTRACT
Condition:
Antibiotic Resistant Infection;COVID-19Primary outcome:
Multidrug resistant bacteria prevalence;Multidrug resistant bacteria transmission;Hand Hygiene and Personal Protective Equipment Use Compliance;Antibiotic use analysisCriteria:
Inclusion Criteria:
- All adult patients discharged from Covid wards and non Covid wards (ICU and internal
medicine wards)
Exclusion Criteria:
- Patients discharged within 48 hours of admission
- Patients who either live outside the city of Malang or their address is unclear
6.
ClinicalTrials.gov; 06/06/2021; TrialID: NCT04927936
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04927936
ABSTRACT
Condition:
Covid19Intervention:
Biological: Vaccination once with Janssen vaccine (only priming);Biological: Vaccination with Janssen vaccine followed with Janssen vaccine (homologous boosting).;Biological: Vaccination with Janssen vaccine followed with Moderna vaccine (heterologous boosting).;Biological: Vaccination with Janssen vaccine followed with Pfizer vaccine (heterologous boosting).Primary outcome:
Determination of antibodies by a quantitative IgG assay (LIAISON SARS-CoV-2 TrimericS IgG essay) 28 days after boosterCriteria:
Inclusion Criteria:
1. Participant is willing and able to give written informed consent for participation in
the trial.
2. Adult (male/female) between 18 and 65 years old
3. Sufficient level of the Dutch language to undertake all study requirements
Exclusion Criteria:
1. Adults younger than 18 or older than 65 years
2. Adults already vaccinated with other vaccine then Janssen
3. Previously had a COVID-19 infection
4. History of allergic reaction likely to be exacerbated by any component of study
vaccines (e.g. hypersensitivity to the active substance or any of the ingredients of
the Janssen/Pfizer/Moderna vaccine).
5. Adults that are pregnant or have a wish to become pregnant within 6 months
6. Currently being treated for cancer
7. Severe kidney failure or dialyses dependent
8. Status after organ-, stem cell- or bone marrow transplantation
9. Use of immunosuppressant's
10. Epilepsy
11. HIV
12. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or
prior history of significant bleeding of bruising following injections of vene
puncture
13. Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral
anticoagulants (i.e. apixaban, dabigatran etc).
14. Participants who are currently participating in another research trial.
15. All regular contra-indications of the vaccines will be applied.
7.
ClinicalTrials.gov; 17/05/2021; TrialID: NCT04904445
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04904445
ABSTRACT
Condition:
Cystic FibrosisPrimary outcome:
To evaluate SARS-CoV-2 seroprevalence;To examine the associations;To perform a longitudinal comparisonCriteria:
Inclusion Criteria:
- Consenting people with cystic fibrosis of any age, genotype, transplant status and
disease severity.
Exclusion Criteria:
- Refusal to give informed consent
- Contraindication to venepuncture.
Participants already enrolled in a clinical trial are eligible for enrollment in this
study. Inclusion in CAR-CF should not preclude enrollment in other observational clinical
trial studies or clinical trials of an investigational medicinal product (CTIMP).
8.
ClinicalTrials.gov; 03/02/2021; TrialID: NCT04743232
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04743232
ABSTRACT
Condition:
Covid19;Cardiac ArrestIntervention:
Other: Decision tool for cliniciansPrimary outcome:
ICU-admissionsCriteria:
Inclusion Criteria:
- adults with COVID19 (proven by polymerase chain reaction, or with strong clinical
suspicion based on clinical features and/or radiodiagnostics)
Exclusion Criteria:
- minors
9.
NL-OMON; 2021-01-25; TrialID: NL-OMON23834
Clinical Trial Register
| ICTRP | ID: ictrp-NL-OMON23834
ABSTRACT
Condition:
Post-Intensive Care Syndrome Family (PICS-F), post-traumatic stress disorder, anxiety, depressionIntervention:
The ICU-VR-F module was adapted to a prior designed patient VR module to match the need of relatives. The current VR module was designed with the aim to show relatives relevant and truthful information regarding their ICU treatment. The point of view for the camera was the field of vision of the mock patient lying in a hospital bed. Based on focus group meetings and previous studies, the following information was included in the module: 1) an introduction by an intensivist and an ICU nurse to welcome the patient to the ICU and VR environment explaining daily movements at an ICU, 2) explanation of monitors and noises in an ICU room, 3) information regarding mechanical ventilation, intubation and tracheal tube suction, 4) necessity of central/peripheral lines and IV/drips, 5) information and necessity of the treatment team and ICU workflow.After randomization, participants in the intervention group will receive ICU-VR using head-mounted display VR (Oculus Go, Irvine, CA, CE: R-CMM-OC8-MH-A), followed by the possibility to watch the ICU-VR-F module again whenever desirable via cardboard VR glasses through an access link. The number of sessions via the cardboard VR glasses will be noted. Participants who are not allowed to visit the hospital due to COVID-19 regulations, i.e., mandatory self-quarantine, inability to visit the ICU, or a limited number of visitors, will only receive ICU-VR-R using cardboard VR glasses.
Primary outcome:
The primary endpoint is the effect of ICU-VR-F on PTSD, anxiety, depression, and quality of life in relatives of ICU patients up to six months after ICU discharge. PTSD will be assessed using the impact of event scale-revised (IES-R), anxiety and depression using the hospital anxiety and depression scale (HADS), and quality of life using the RAND-36.Criteria:
Inclusion criteria: • =18 years old• First/second degree relatives (spouses, sibling, parent, children), responsible for decision making, sharing the same household (in absence of next of kin), or close friend (in absence of other relatives)
• Able to understand the Dutch language
• In possession of a smartphone/tablet compatible to watch ICU-VR-F at home
• Signed informed-consent
Exclusion criteria: • Lack of a formal home address
• Family members of patients with an ICU-LOS <72 hours
• Relatives of patients who decease during ICU treatment will retrospectively be excluded from the main analysis
10.
ClinicalTrials.gov; 12/01/2021; TrialID: NCT04711954
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04711954
11.
ClinicalTrials.gov; 12/10/2020; TrialID: NCT04589949
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04589949
ABSTRACT
Condition:
Covid19Intervention:
Biological: ConvP;Biological: FFPPrimary outcome:
Highest disease statusCriteria:
Inclusion Criteria:
- RT-PCR-confirmed COVID-19.
- Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoea, loss of taste or
smell, diarrhea, falls or confusion)
- 70 years or older OR 50-69 years and 1 or more of the risk factors described in the
protocol
Exclusion Criteria:
- Life expectancy <28 days in the opinion of the treating physician
- Patient or legal representative is unable to provide written informed consent
- Symptomatic for 8 days or more
- Being admitted to the hospital at the informed consent procedure
- Known previous history of transfusion-related acute lung injury
- Known Immunoglobulin A (IgA) deficiency
12.
NL-OMON; 2020-08-14; TrialID: NL-OMON20934
Clinical Trial Register
| ICTRP | ID: ictrp-NL-OMON20934
ABSTRACT
Condition:
COVID-19, anxiety, depression, post-traumatic stress disorder (PTSD)Intervention:
Intensive Care Unit Specific Virtual Reality:An interdisciplinary team of three intensivists, a psychologist, a psychiatrist, two ICU nurses, a post-ICU patients, a VR/film director and a researcher designed the Intensive Care specific Virtual Reality (ICU-VR) module based on previous studies. The content available for other VR exposure therapy-based treatments are often based on or preselected out of standardized material. For different illnesses, specific VR content must be developed to improve response and specific traumatic experiences or fears. For the COVID-19 patients we therefore developed a specific COVID-19 module. Real ICU nurses and ICU physicians were used to re-enact a typical day/treatment for a mock patients undergoing COVID related ICU treatment. The module will be watched via HMD-VR glasses (Oculus Go, Irvine, CA, CE: R-CMM-OC8-MH-A). Participants will be allowed to move their head freely so that they can experience all aspects of the virtual environment.
This way of ICU-VR is safe and feasible, as determined in previous research, and has been already approved for use in sepsis patients in our hospital (https://www.trialregister.nl/trial/6611). The only difference of the concurrent module is that this will be a COVID-19 specific ICU-VR module (with extra explanation about COVID-19, prone position and isolation measures).
Primary outcome:
The effect of ICU-VR, given 3 months after hospital discharge, on the severity and prevalence of psychological sequelae, such as PTSD, anxiety and depression, and the health-related quality of life in ICU patients treated for COVID-19 up to 6 months after discharge, assessed using a between-group analysis.Criteria:
Inclusion criteria: - Above 18 years old- A positive SARS-CoV-2 PCR with clinical signs of COVID-19 necessitating ICU care
- Able to understand the Dutch language
- Signed informed-consent
Exclusion criteria: - Documented active, established psychiatric disease (for instance personality disorders or schizophrenia)
- Admitted with or a history of primary neurological impairment necessitating ICU admission to or discharge of the ICU (patients admitted with traumatic brain injury, CVA, stroke, meningitis). Patients with a medical history of delirium are eligible, if symptoms of delirium are not present at the time of inclusion.
- Lack of formal home address
13.
ClinicalTrials.gov; 02/06/2020; TrialID: NCT04488562
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04488562
ABSTRACT
Condition:
COVID-19;Pulmonary FibrosisPrimary outcome:
VAS;VAS;VAS;Temperature;Oxygen measurements;Oxygen measurements;Oxygen measurements;Forced Vital Capacity (FVC) home spirometry in %;Forced Vital Capacity (FVC) home spirometry in L;Forced Vital Capacity (FVC) home spirometry in %;Forced Vital Capacity (FVC) home spirometry in L;Forced Vital Capacity (FVC) home spirometry in L;Forced Vital Capacity (FVC) home spirometry in %;Forced Vital Capacity (FVC) hospital spirometry in %;Forced Vital Capacity (FVC) hospital spirometry in L;Forced Vital Capacity (FVC) hospital spirometry in %;Forced Vital Capacity (FVC) hospital spirometry in L;Forced Vital Capacity (FVC) hospital spirometry in %;Forced Vital Capacity (FVC) hospital spirometry in L;Adherence to weekly home spirometry;EQ5D;EQ5D;EQ5D;EQ5D;EQ5D;EQ5D;FAS;FAS;FAS;FAS;FAS;FAS;GRoC;GRoC;GRoC;GRoC;GRoC;GRoC;ABC tool;ABC tool;ABC tool;ABC tool;ABC tool;ABC toolCriteria:
Inclusion Criteria:
- Patients admitted to the hospital with proven COVID-19 infection
- Abnormalities on Chest X-ray/HRCT due to COVID-19 infection
Exclusion Criteria:
- Not able to speak, read or write in the native language of the country where the
patient is included
- Not able to comply to the study protocol, according to the judgement of the
investigator and/or patient
- No access to internet
14.
ClinicalTrials.gov; 31/03/2020; TrialID: NCT04342182
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04342182
ABSTRACT
Condition:
COVID-19Intervention:
Biological: Convalescent plasmaPrimary outcome:
Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes firstCriteria:
Inclusion Criteria:
- Patients with PCR confirmed COVID disease
- Admitted to the hospital
- The most recent PCR positive sample is <96hrs old
- Written informed consent by patient or legal patient representative
- Age at least 18 years
Exclusion Criteria:
- Participation in another intervention trial on the treatment of COVID-19 that falls
under the Dutch law human research (WMO) and in which individual patients are
randomized to different treatment options
- Known IgA deficiency
- Invasive ventilation for already >96 hours
Donors: Eligibility for plasma donation
Inclusions Criteria:
- A history of COVID infection that was documented by PCR
- Known ABO-Resus(D) blood group
- A screening for irregular antibodies with a titer = 1:32
- Asymptomatic for at least 14 days
- Written informed consent regarding the plasmapheresis procedure
- Tested negative for HIV, HBV, HCV, HEV, HTLV and syfilis
Exclusion Criteria:
- Age <18 years and > 65 years
- Weight <50kg
- Medical history of heart failure
- History of transfusion with red blood cells, platelets or plasma
- History of organ- or tissue transplant
- A cumulative stay in the United Kingdom of = 6 months in the period between 01-01-1980
and 31-12-1996
- A history of i.v. drug use
- Insulin dependent diabetes
- An underlying severe chronic illness (i.e. history of heart failure, cancer or stroke)
- Tested positive for HLA- or HNA-antibodies