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

Primary Purpose

SARS-CoV-2 Infection

Status
Terminated
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Equine COVID-19 Antiserum
Standard of care
Sponsored by
Bharat Serums and Vaccines Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring 2019 Novel Coronavirus Disease, COVID19, Coronavirus Disease 2019

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jehangir Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care

Standard of care.

Arm Description

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

Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered

Outcomes

Primary Outcome Measures

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]
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Proportion (percent) of patients turning COVID-19 negative
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)
Proportion (percent) of patients turning COVID-19 negative

Secondary Outcome Measures

Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Proportion (percent) of patients patients turning COVID-19 negative
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Proportion (percent) of patients patients turning COVID-19 negative
Phase 1 Exploratory outcome
Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Phase 1 Exploratory outcome
Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Phase 1-Exploratory outcome
Mean reduction in WHO clinical progression scale
Phase 1-Exploratory outcome
Mean reduction in WHO clinical progression scale
Phase 1- Exploratory outcome
Mean reduction in WHO clinical progression scale
Phase 1- Exploratory outcome
Mean reduction in WHO clinical progression scale
Phase 1- Exploratory outcome
Mean reduction in WHO clinical progression scale
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
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Proportion (percent) of patients turning COVID-19 negative
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Proportion (percent) of patients turning COVID-19 negative
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale

Full Information

First Posted
March 23, 2021
Last Updated
October 12, 2022
Sponsor
Bharat Serums and Vaccines Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04834908
Brief Title
Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection
Acronym
PROTECT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Closed as no eligible patient.
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bharat Serums and Vaccines Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
Keywords
2019 Novel Coronavirus Disease, COVID19, Coronavirus Disease 2019

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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. Each patient will receive either of the dose BSVEQAb - 5 mg/kg or 10 mg/kg body weight and all will receive standard of care Based on the results of phase 1 study the phase 2 shall be initiated. In phase 2 study one group will receive the tolerable dose of BSVEQAb selected along with standard of care. The second group will receive only standard of care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care.
Arm Type
Active Comparator
Arm Description
Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered
Intervention Type
Biological
Intervention Name(s)
Equine COVID-19 Antiserum
Other Intervention Name(s)
F(ab)2, BSVEQAb, EqAb-COV-19
Intervention Description
Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided
Primary Outcome Measure Information:
Title
Phase 1 Unexpected serious adverse events
Description
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]
Time Frame
Up to Day 28
Title
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Description
Proportion (percent) of patients turning COVID-19 negative
Time Frame
Day 5
Title
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)
Description
Proportion (percent) of patients turning COVID-19 negative
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Description
Proportion (percent) of patients patients turning COVID-19 negative
Time Frame
Day 5
Title
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Description
Proportion (percent) of patients patients turning COVID-19 negative
Time Frame
Day 7
Title
Phase 1 Exploratory outcome
Description
Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Time Frame
Day 10
Title
Phase 1 Exploratory outcome
Description
Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Time Frame
Day 14
Title
Phase 1-Exploratory outcome
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 3 from Baseline
Title
Phase 1-Exploratory outcome
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 5 from Baseline
Title
Phase 1- Exploratory outcome
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 7 from Baseline
Title
Phase 1- Exploratory outcome
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 14 from Baseline
Title
Phase 1- Exploratory outcome
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 28 from Baseline
Title
Phase 2 Unexpected serious adverse events
Description
Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration
Time Frame
up to Day 28
Title
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Description
Proportion (percent) of patients turning COVID-19 negative
Time Frame
Day 10
Title
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Description
Proportion (percent) of patients turning COVID-19 negative
Time Frame
Day 14
Title
Phase 2 Change in WHO clinical progression scale
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 3 from baseline
Title
Phase 2 Change in WHO clinical progression scale
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 5 from baseline
Title
Phase 2 Change in WHO clinical progression scale
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 7 from baseline
Title
Phase 2 Change in WHO clinical progression scale
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 14 from baseline
Title
Phase 2 Change in WHO clinical progression scale
Description
Mean reduction in WHO clinical progression scale
Time Frame
Day 28 from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age Phase 1: ≥ 18 years to ≤ 55 years Phase 2: ≥ 18 years to ≤ 65 years Are male or non-pregnant females who agree to contraceptive requirements. Patients with RT-PCR confirmed COVID-19 in ≤ 72 hours prior to randomization [Ct ≥ 24]. Have SpO2<94% (range 90-93%) on room air. Have one or more of the following- dyspnea, fever, cough, respiratory rate ≥ 24 per minute and heart rate up to 120 per minute. Patients who agree to participate in the study and follow all study related procedures Exclusion Criteria: Require mechanical ventilation Have oxygen saturation less than or equal to 89 percent Patients re-infected with SARS-CoV-2 Suspected or proven serious active bacterial fungal viral or other infection Patients with positive skin test with IP Patients with known equine allergies or past medical history of serum sickness Patient who are HIV, HCV, HbsAg positive or immunocompromised Patients with significant co-morbidities at screening Moribund state Pregnant or nursing women Participating in other clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Jagannathan
Organizational Affiliation
Bharat Serums and Vaccines Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jehangir Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

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