Evaluation of Equine antibody treatment in patient with COVID 19 infectio

Phase 1

Active, not recruiting

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/02/031566
• Lead Sponsor: Bharat Serums and Vaccines ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1 <br/ ><br>Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration <br/ ><br> <br/ ><br>Phase 2 <br/ ><br>Proportion (percent) of patients turning COVID-19 negative Day 5 and Day 7Timepoint: Phase 1 <br/ ><br>Baseline through Day 28 <br/ ><br> <br/ ><br>Phase 2 <br/ ><br>Day 5 and Day 7

Secondary Outcome Measures

Name	Time	Method
Phase 1 <br/ ><br>Exploratory Outcome <br/ ><br>Mean reduction in WHO clinical progression scaleTimepoint: Day 3, 5, 7, 14, 28;Phase 1 <br/ ><br>Exploratory Outcome <br/ ><br>Proportion (percent) of patients turning COVID-19 negativeTimepoint: day 10 and 14;Phase 1 <br/ ><br>Proportion (percent) of patients turning COVID-19 negativeTimepoint: <br/ ><br>Day 5 and Day 7 <br/ ><br> <br/ ><br>;Phase 2 <br/ ><br>Mean reduction in WHO clinical progression scaleTimepoint: Day 3, 5, 7, 14, 28;Phase 2 <br/ ><br>Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administrationTimepoint: Baseline through Day 28;Phase 2 <br/ ><br>Proportion of patients turning COVID-19 negativeTimepoint: Day 10, 14