Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

SARS-CoV-2 Infection Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04834908
• Other study ID #: BSV_EQ-AB_20_08
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 27, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: October 2022
• Source: Bharat Serums and Vaccines Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

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

Locations

Country	Name	City	State
India	Jehangir Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Bharat Serums and Vaccines Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	Up to Day 28
Primary	Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Proportion (percent) of patients turning COVID-19 negative	Day 5
Primary	Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)	Proportion (percent) of patients turning COVID-19 negative	Day 7
Secondary	Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)	Proportion (percent) of patients patients turning COVID-19 negative	Day 5
Secondary	Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)	Proportion (percent) of patients patients turning COVID-19 negative	Day 7
Secondary	Phase 1 Exploratory outcome	Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)	Day 10
Secondary	Phase 1 Exploratory outcome	Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)	Day 14
Secondary	Phase 1-Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 3 from Baseline
Secondary	Phase 1-Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 5 from Baseline
Secondary	Phase 1- Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 7 from Baseline
Secondary	Phase 1- Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 14 from Baseline
Secondary	Phase 1- Exploratory outcome	Mean reduction in WHO clinical progression scale	Day 28 from Baseline
Secondary	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	up to Day 28
Secondary	Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Proportion (percent) of patients turning COVID-19 negative	Day 10
Secondary	Phase 2 Patients turning COVID-19 negative (RT-PCR negative)	Proportion (percent) of patients turning COVID-19 negative	Day 14
Secondary	Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 3 from baseline
Secondary	Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 5 from baseline
Secondary	Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 7 from baseline
Secondary	Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 14 from baseline
Secondary	Phase 2 Change in WHO clinical progression scale	Mean reduction in WHO clinical progression scale	Day 28 from baseline