Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

NCT04834908 | Terminated Phase 1 DMC

• 1 other identifier: BSV_EQ-AB_20_08
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Keywords

2019 Novel Coronavirus Disease; COVID19; Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)

  Day 5

• Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)

  Day 7

• Phase 1 Exploratory outcome

  Day 10

• Phase 1 Exploratory outcome

  Day 14

• Phase 1-Exploratory outcome

  Day 3 from Baseline

Study Arms (2)

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

EXPERIMENTAL

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; Drug: Standard of care

Standard of care.

ACTIVE COMPARATOR

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

Drug: Standard of care

Interventions

Equine COVID-19 Antiserum BIOLOGICAL

Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.

Also known as: F(ab)2, BSVEQAb, EqAb-COV-19

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

Standard of care DRUG

Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bharat Serums and Vaccines Limited: lead

Study Sites (1)

Jehangir Hospital

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ramesh Jagannathan

  Bharat Serums and Vaccines Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 8, 2021
• Study Start: July 27, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)