Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is 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].

BSV has developed Equine COVID-19 antiserum from horse serum for the use in COVID-19 infection. The indication proposed is to provide passive immunization to the COVID-19 infected patient thereby reducing the viral load and prevention of disease progression.

Clinical phase 1 and phase 2 studies have been planned to be conducted. The phase 1 study will be conducted on two dosages to find the safety and tolerability in patients. Based on the results of phase 1 study the phase 2 shall be initiated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bharat Serums and Vaccines Limited
• Treatments: Immune Sera

Criteria

Inclusion Criteria:

1. Age 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

Exclusion Criteria:

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