COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN98052401

Bhanu Prakash Reddy Attunuru

drbhanu.prakash@aighospitals.com

2022-01-06

Not recruiting

RCT

Randomized

Parallel

Not reported

unclear

Prevention

1. Adult male or female human volunteer aged 18-65 years (inclusive of both) and not vaccinated for COVID-19/influenza, willing and able to provide written, signed and dated informed consent 2. Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result 3. Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit 4. No medical history or evidence of COVID-19 5. No acute infections and/or respiratory diseases within 14 days before enrollment 6. No evidence of vaccine-induced reactions or complications after receiving immunobiological products in the past medical history 7. Willing to give consent to use effective contraception methods during the study 8. Negative urine pregnancy test at the screening visit (for childbearing aged women) 9. Negative human immunodeficiency virus (HIV 1 & 2), syphilis, hepatitis B and C test results

1. Aged <18 years of age 2. Any vaccination/immunization within 30 days before enrollment 3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before enrollment 4. Any treatment with immunosuppressive therapy within 3 months before enrollment 5. Any drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on enrollment day 6. Any neoplasms in the past medical history 7. Donated blood or plasma within 3 months before enrollment 8. Any history or evidence of splenectomy 9. Any immunodeficiency state 10. Any history or evidence of anorexia or protein deficiency of any origin 11. Alcohol or drug addiction in the past medical history 12. Participation in any other interventional clinical trial within 3 months 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 14. Pregnancy or breastfeeding 15. Subjects who test positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies

4

Asian Healthcare Foundation

18

65

India

Healthy volunteers

N/A

200

Immunogenicity: neutralising antibody titres against S1/S2 and RBD measured by electrochemiluminescence at baseline; 28 days and 45 days after complete vaccination

Not reported

[{"arm_notes": "2;Days0-28", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days0-28", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1+1;Days 0 (Covishield) and 28 (Covaxin)", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1+1;Days 0 (Covaxin) and 28 (Covishield)", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}]