COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=69267

Dr Padmanabha Shenoy

drdpshenoy@gmail.com

2022-05-17

Recruiting

nonRCT

Non-randomized

Single group assignment

Not reported

single-center

Prevention

1. Patient above 18 yrs of age <br/ >2. Patients with diagnosed case <br/ >of Autoimmune Rheumatic Disease <br/ > 3. Patients who had completed Both dose of AZD 1222 vaccine and had a documentedCovid 19 infection (irrespective of the order ofImmune hit) <br/ >4. Patients who had completed both dose of <br/ >AZD1222 vaccine with no history of Covid infection (Controlgroup) <br/ > 5. Patients who are willing to provide informed consent <br/ >and to comprehend with the study <br/ >

1. Patients with unstable disease activity and past history of flare <br/ >following vaccinations. <br/ >2. Patients with non-repopulated peripheral B cell <br/ >3. Patients with history of allergic reaction to vaccine or its <br/ >components <br/ >4. Patients who received live vaccine within 2 months prior the study

1

Centre for Arthritis and Rheumatism Excellence CARE

18

100

India

High risk patients

N/A

200

Effect of booster dose will be assessed based on <br/ >1. Anti SARS CoV 2S Antibody levels after 1 <br/ >month of booster dose <br/ >2. Neutralization antibody levels against Omicron <br/ >and Delta variant <br/ >Timepoint: 1 month of booster dose <br/ > <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

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