COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62803

Dr Anuroopa

drshenoy@drshenoycare.com

2021-12-27

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

Patient above 18 yrs to 80 yrs of age <br/ > 2. Patients with diagnosed case of Autoimmune Rheumatic Disease <br/ > 3. Patients who are on stable doses of immunosuppressants for more than 3 months and on stable doses of more than 3 weeks in case of steroids <br/ > 4. Patients who are seronegative or suboptimal response after both doses of Covid 19 vaccine <br/ > 5. Patients who are willing to provide informed consent and to comprehend with the study

1. Patients with unstable disease activity and past history of flare following vaccinations. <br/ > 2. Patients with non-repopulated peripheral B cell, if they have taken B cell depletion therapy 3. Patients with past history of Covid infection 4. Patients with history of allergic reaction to vaccine or its components <br/ > 5. Patients who received any live vaccine within 2 months prior the study. 6. Patients with history of arterial/ venous thrombosis, demyelinating syndromes or diagnosed case of vasculitis

2

Dr Padmanabha Shenoy

18

99

India

Healthy volunteers

N/A

200

Effect of booster dose will be assessed based on <br/ >1. T cell response after 1 month of booster dose <br/ >2. Anti SARS CoV 2S Antibody levels after 1 month of booster dose <br/ >3. Neutralization antibody levels <br/ >Timepoint: 1 month

| Declared number of arm (3.0) differs from found arms (4.0)

Not reported

[{"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2172, "treatment_name": "Bbv152", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]