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Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

NCT04834908 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-10-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

Equine COVID-19 Antiserum

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

DRUG

Standard of care

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

Sponsors & Collaborators

  • Bharat Serums and Vaccines Limited

    lead INDUSTRY

Principal Investigators

  • Ramesh Jagannathan · Bharat Serums and Vaccines Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2022-05-25
Completion
2022-05-25

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04834908 on ClinicalTrials.gov