COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04805125

Not reported

Not reported

2021-03-18

Completed

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: all patients registered with informed consent from participating cohorts aged ≥18 years additional consent for participation in the specific sub-protocol trial inclusion criteria for pilot trial: all patients with either a chronic hiv infection or recipients of solid organs registered with informed consent from the shcs and stcs cohorts aged ≥18 years patients with solid organ transplantation of lungs or kidneys at least one month post-transplantation with a prednisone dose of 20mg or less. covid-19 vaccination recommended by treating physician inclusion criteria for 2. sub protocol (observational study): third covid-19 vaccination recommended by treating physician and administered in the frame of clinical routine inclusion criteria for 3. substudy. - patients receiving a new bivalent (wuhan/omicron ba.1) mrna sars-cov-2 vaccine in the frame of clinical routine, according to the treating physician

acute symptomatic sars-cov-2 infection, influenza or other acute respiratory tract infection known allergy or contra-indications for vaccines or any vaccine components any emergency condition requiring immediate hospitalization for any condition patients with previous pcr documented sars-cov-2 infection and, or documented antibodies less than 3 months prior to screening visit (day 0) exclusion criteria for pilot trial: pregnancy acute symptomatic sars-cov-2 infection, influenza or other acute respiratory tract infection known allergy or contra-indications for vaccines or any vaccine components any emergency condition requiring immediate hospitalization for any condition patients with previous pcr documented sars-cov-2 infection and, or documented antibodies less than 3 months prior to randomisation patients with solid organ transplantation (lung or kidney) with the following conditions: solid organ transplant recipients less than one month post-transplantation solid organ transplant recipients with the use of t-cell/b-cell depleting agents in the last 3 months (i. e induction treatment in standard risk or high-risk immunological situation or rejection treatment). solid organ transplant recipients with the need of pulse corticosteroids (>100mg prednisone or equivalent) in the last 1 month or who have received atg or rituximab in the last 6 months solid organ transplant recipients with the need of any kind of chemotherapy treatment

2

University Hospital, Basel, Switzerland

18

100

Switzerland

High risk patients

N/A

610

Clinical Outcome: COVID-19 burden of diseases (BOD);Duration of RCT set up (specific endpoint related to trial conduct feasibility);immunological outcome: change in anti-Nucleocapsid (N) response;immunological outcome: change in pan-Ig antibody response (pan-Ig anti-S1-RBD);immunological outcome: change in SARS-CoV-2-binding antibodies;Number of participants with newly PCR-confirmed symptomatic COVID-19 infection;Number of participants with newly polymerase chain reaction (PCR)-confirmed asymptomatic COVID-19 infection;Number of participants with severe COVID-19 infection;Patient consent rate;Proportion of missing data for all baseline variables from routinely collected cohort data;Proportion of missing data for all clinical outcomes;SARS-CoV-2-specific antibodies;SARS-CoV-2-specific titers;The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed in the observational second sub- protocol;Time of patient recruitment from activation of first study site until 380 patients are randomised;Time of patient recruitment from activation of first study site until 40 patients are randomised

None

Phase 3

[{"arm_notes": "2;days0-28", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;days0-21", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]