Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

Phase 2TerminatedNCT04834908

Bharat Serums and Vaccines Limited7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

SARS-CoV-2 Infection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 \[Baseline through Day 28\]

Time frame: Up to Day 28

Phase 2 Patients turning COVID-19 negative (RT-PCR negative)

Proportion (percent) of patients turning COVID-19 negative

Time frame: Day 5

Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)

Proportion (percent) of patients turning COVID-19 negative

Time frame: Day 7

Secondary Outcomes

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

Proportion (percent) of patients patients turning COVID-19 negative

Time frame: Day 5

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

Proportion (percent) of patients patients turning COVID-19 negative

Time frame: Day 7

Phase 1 Exploratory outcome

Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)

Time frame: Day 10

Phase 1 Exploratory outcome

Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)

Time frame: Day 14

Phase 1-Exploratory outcome

Mean reduction in WHO clinical progression scale

Time frame: Day 3 from Baseline

Phase 1-Exploratory outcome

Mean reduction in WHO clinical progression scale

Time frame: Day 5 from Baseline

Phase 1- Exploratory outcome

Mean reduction in WHO clinical progression scale

Time frame: Day 7 from Baseline

Phase 1- Exploratory outcome

Mean reduction in WHO clinical progression scale

Time frame: Day 14 from Baseline

Phase 1- Exploratory outcome

Mean reduction in WHO clinical progression scale

Time frame: Day 28 from Baseline

Phase 2 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

Time frame: up to Day 28

Phase 2 Patients turning COVID-19 negative (RT-PCR negative)

Proportion (percent) of patients turning COVID-19 negative

Time frame: Day 10

Phase 2 Patients turning COVID-19 negative (RT-PCR negative)

Proportion (percent) of patients turning COVID-19 negative

Time frame: Day 14

Phase 2 Change in WHO clinical progression scale

Mean reduction in WHO clinical progression scale

Time frame: Day 3 from baseline

Phase 2 Change in WHO clinical progression scale

Mean reduction in WHO clinical progression scale

Time frame: Day 5 from baseline

Phase 2 Change in WHO clinical progression scale

Mean reduction in WHO clinical progression scale

Time frame: Day 7 from baseline

Phase 2 Change in WHO clinical progression scale

Mean reduction in WHO clinical progression scale

Time frame: Day 14 from baseline

Phase 2 Change in WHO clinical progression scale

Mean reduction in WHO clinical progression scale

Time frame: Day 28 from baseline

Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes