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Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

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

NCT04834908•Bharat Serums and Vaccines Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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
+1 more criteria

Locations (1)

Jehangir Hospital

Pune, Maharashtra, India

Key Dates

Start Date

July 27, 2021

Primary Completion Date

May 25, 2022

Completion Date

May 25, 2022

Last Updated

October 14, 2022

Enrollment

ACTUAL participants

Conditions

SARS-CoV-2 Infection

Interventions

Equine COVID-19 Antiserum

BIOLOGICAL

Standard of care

DRUG

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

NCT05141058

SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

Physiology of Long COVID-19 and the Impact of Cardiopulmonary Rehabilitation on Quality-of-Life and Functional Capacity