Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

NCT ID: NCT04834908

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2022-05-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Equine COVID-19 Antiserum

Intervention Type: BIOLOGICAL

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

Standard of care

Intervention Type: DRUG

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

Standard of care.

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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

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

Interventions

Equine COVID-19 Antiserum

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

Intervention Type: BIOLOGICAL

Standard of care

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

Intervention Type: DRUG

Other Intervention Names

F(ab)2, BSVEQAb, EqAb-COV-19

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bharat Serums and Vaccines Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramesh Jagannathan

Role: PRINCIPAL_INVESTIGATOR

Bharat Serums and Vaccines Ltd

Locations

Jehangir Hospital

Pune, Maharashtra, India

Countries

India

Other Identifiers

BSV_EQ-AB_20_08

Identifier Type: -

Identifier Source: org_study_id