A Prospective, Randomized, Multi-center, Open label, Phase 1/2 study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab)2] (BSVEQAb) plus Standard of Care in Comparison to Standard of Care alone in COVID-19 RT-PCR positive Patients (PROTECT) - PROTECT

Bharat Serums and Vaccines ltd0 sites0 target enrollmentStarted: TBDLast updated: February 6, 2023

Trial Snapshot

No summary available.

•Phase 1: >= 18 years to <= 55 years
•Phase 2: >= 18 years to <= 65 years
•2. Are male or non-pregnant females who agree to contraceptive requirements.
•3. Patients with RT-PCR confirmed COVID-19 in <= 72 hours prior to randomization [Ct >= 24].
•4. Have SpO2 <94% (range 90-93%) on room air.
•5. Have one or more of the following- dyspnea, fever, cough, respiratory rate >= 24 per minute and heart rate up to 120 per minute.
•6. Patients who agree to participate in the study and follow all study related procedures

•1. Require mechanical ventilation
•2. Have oxygen saturation less than or equal to 89 percent
•3. Patients re-infected with SARS-CoV-2
•4. Suspected or proven serious active bacterial fungal viral or other infection
•5.Patients with positive skin test with IP
•6. Patients with known equine allergies or past medical history of serum sickness
•7. Patient who are HIV, HCV, HbsAg positive or immunocompromised
•8. Patients with significant co-morbidities at screening
•9. Moribund state
•10. Pregnant or nursing women
•11. Participating in other clinical trial

Sponsor

Bharat Serums and Vaccines ltd