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

Bharat Serums and Vaccines

Status and phase: Terminated; Phase 2; Phase 1

Conditions: SARS-CoV-2 Infection

Treatments: Biological: Equine COVID-19 Antiserum; Drug: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04834908

BSV_EQ-AB_20_08

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

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

Experimental group

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:

Drug: Standard of care

Biological: Equine COVID-19 Antiserum

Standard of care.

Active Comparator group

Description:

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

Treatment:

Drug: Standard of care