Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

Phase 1

Terminated

• Conditions: SARS-CoV-2 Infection
• Interventions: Biological: Equine COVID-19 Antiserum; Drug: Standard of care

• Registration Number: NCT04834908
• Lead Sponsor: Bharat Serums and Vaccines Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2021-07-27
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care	Equine COVID-19 Antiserum	Dose of BSVEQAb - 5 mg/kg or 10 mg/kg body weight. It is administered as a single dose intravenously after diluting in 100 -150 ml saline. The infusion will be done over 1 to 2 hours. Standard of care for treatment of COVID-19 positive patients
Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care	Standard of care	Dose of BSVEQAb - 5 mg/kg or 10 mg/kg body weight. It is administered as a single dose intravenously after diluting in 100 -150 ml saline. The infusion will be done over 1 to 2 hours. Standard of care for treatment of COVID-19 positive patients
Standard of care.	Standard of care	Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered

Primary Outcome Measures

Name	Time	Method
Phase 1 Unexpected serious adverse events	Up to Day 28	Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration \[Baseline through Day 28\]
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Day 5	Proportion (percent) of patients turning COVID-19 negative
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)	Day 7	Proportion (percent) of patients turning COVID-19 negative

Secondary Outcome Measures

Name	Time	Method
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Day 14	Proportion (percent) of patients turning COVID-19 negative
Phase 2 Unexpected serious adverse events	up to Day 28	Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration
Phase 1-Exploratory outcome	Day 5 from Baseline	Mean reduction in WHO clinical progression scale
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)	Day 7	Proportion (percent) of patients patients turning COVID-19 negative
Phase 1- Exploratory outcome	Day 28 from Baseline	Mean reduction in WHO clinical progression scale
Phase 1 Exploratory outcome	Day 14	Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Phase 2 Change in WHO clinical progression scale	Day 28 from baseline	Mean reduction in WHO clinical progression scale

Trial Locations

Locations (1)

Jehangir Hospital; 🇮🇳 Pune, Maharashtra, India