Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: M199- Osteoarthritis, unspecified site Health Condition 3: M058- Other rheumatoid arthritis with rheumatoid factor Health Condition 4: M468- Other specified inflammatory spondylopathies Health Condition 5: M329- Systemic lupus erythematosus, unspecified Health Condition 6: M349- Systemic sclerosis, unspecified
Conditions
Interventions
Intervention1: Chadox1 Ncov -19 Corona Virus: patients without SARS -CoV -2 antibody seroconversion / inadequate seroconversion who has taken Chadox1 Ncov -19 Corona Virus/BBV152 both doses radnomised
Sponsors
Dr Padmanabha Shenoy
Eligibility
Inclusion criteria
Inclusion criteria: Patient above 18 yrs to 80 yrs of age 2. Patients with diagnosed case of Autoimmune Rheumatic Disease 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 4. Patients who are seronegative or suboptimal response after both doses of Covid 19 vaccine 5. Patients who are willing to provide informed consent and to comprehend with the study
Exclusion criteria
Exclusion criteria: 1. Patients with unstable disease activity and past history of flare following vaccinations. 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of booster dose will be assessed based on 1. T cell response after 1 month of booster dose 2. Anti SARS CoV 2S Antibody levels after 1 month of booster dose 3. Neutralization antibody levels Timepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who required rescue therapyTimepoint: 1 month;1. To identify whether there is difference in immunogenicity with regard to the type of additional dose ( Homologous Vs Heterologous) Timepoint: 1 month;2. Proportion of patients who experience solicited local and systemic adverse events post additional dose of vaccine (7 day follow up period following vaccination)Timepoint: 7 days;Proportion of patients who experience significant disease flaresTimepoint: 1 month post vaccination | — |
Countries
India
Contacts
Public ContactDr Anuroopa
Sree Sudheendra Medical Mission Hospital
Outcome results
None listed