Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection (PROTECT)

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

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.

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Biological: Equine COVID-19 Antiserum; Drug: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Jehangir Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with 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	Biological: Equine COVID-19 Antiserum; Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.; Other Names: F(ab)2, BSVEQAb, EqAb-COV-19; Drug: Standard of care; Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided
Active Comparator: Standard of care.; Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered	Drug: Standard of care; Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Unexpected serious adverse events	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]	Up to Day 28
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Proportion (percent) of patients turning COVID-19 negative	Day 5
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)	Proportion (percent) of patients turning COVID-19 negative	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)	Proportion (percent) of patients patients turning COVID-19 negative	Day 5
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)	Proportion (percent) of patients patients turning COVID-19 negative	Day 7
Phase 1 Exploratory outcome	Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)	Day 10
Phase 1 Exploratory outcome	Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)	Day 14
Phase 1-Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 3 from Baseline
Phase 1-Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 5 from Baseline
Phase 1- Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 7 from Baseline
Phase 1- Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 14 from Baseline
Phase 1- Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 28 from Baseline
Phase 2 Unexpected serious adverse events	Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration	up to Day 28
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Proportion (percent) of patients turning COVID-19 negative	Day 10
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Proportion (percent) of patients turning COVID-19 negative	Day 14
Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 3 from baseline
Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 5 from baseline
Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 7 from baseline
Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 14 from baseline
Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 28 from baseline

Collaborators and Investigators

• Sponsor: Bharat Serums and Vaccines Limited
• Investigators: Principal Investigator: Ramesh Jagannathan, Bharat Serums and Vaccines Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COVID19; Coronavirus Disease 2019; 2019 Novel Coronavirus Disease
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections; Physiological Effects of Drugs; Immunologic Factors; Immune Sera
• Other Study ID Numbers: BSV_EQ-AB_20_08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No