COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56122

Dr Shubhadeep Sinha

sreenivasa.chary@heterodrugs.com

2021-05-18

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Adult male or female volunteers aged 18-65 years (inclusive of both) who are not vaccinated for COVID-19/Influenza and willing to give written, signed and dated informed consent to participate in the study <br/ >2. Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result <br/ >3. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit <br/ >4. No acute infections and/or respiratory diseases within 14 days before enrollment <br/ >5. Negative human immunodeficiency virus (HIV 1 & 2), Syphilis, Hepatitis B and C test results

1. Any vaccination/immunization within 30 days before the enrollment <br/ >2. Usage of Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment <br/ >3. Immunosuppressive therapy within 3 months before the enrollment <br/ >4. Donated blood or plasma within 3 months before enrollment <br/ >5. Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past 6 months before enrollment <br/ >6. Participation in any other interventional clinical trial within 3 months <br/ >7. Volunteer is pregnant or breast-feeding <br/ >8. History or evidence of Tuberculosis or chronic systemic infections

2

Hetero Biopharma Limited

18

65

India

Healthy volunteers

N/A

228

Geometric Mean Titre (GMT) Ratio of SARS-CoV-2 glycoprotein-specific antibodiesTimepoint: Day 28 and Day 42

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

Phase 3

[{"arm_notes": "2;Days0-21 (manufactured by Hetero)", "treatment_id": 344, "treatment_name": "Covid-vac combined vector vaccine", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days0-21 (Sputnik V \u2013 Manufactured for RDIF, Russia) ", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]