SARS-CoV-2 InfectionPhase 1/2PROTECTNCT04834908
Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection
A Phase 1/2 study testing Equine COVID-19 Antiserum in people with SARS-CoV-2 Infection, run by Bharat Serums and Vaccines Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Equine COVID-19 Antiserum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIndia
- Study dates
- 27 Jul 2021to 25 May 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Phase 1: ≥ 18 years to ≤ 55 years Phase 2: ≥ 18 years to ≤ 65 years
- Are male or non-pregnant females who agree to contraceptive requirements.
- Patients with RT-PCR confirmed COVID-19 in ≤ 72 hours prior to randomization [Ct ≥ 24].
- Have SpO2<94% (range 90-93%) on room air.
- Have one or more of the following- dyspnea, fever, cough, respiratory rate ≥ 24 per minute and heart rate up to 120 per minute.
- Patients who agree to participate in the study and follow all study related procedures
Who cannot join
- Require mechanical ventilation
- Have oxygen saturation less than or equal to 89 percent
- Patients re-infected with SARS-CoV-2
- Suspected or proven serious active bacterial fungal viral or other infection
- Patients with positive skin test with IP
- Patients with known equine allergies or past medical history of serum sickness
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- Patient who are HIV, HCV, HbsAg positive or immunocompromised
- Patients with significant co-morbidities at screening
- Moribund state
- Pregnant or nursing women
- Participating in other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Equine COVID-19 Antiserum, Standard of care
- Keywords
- 2019 Novel Coronavirus Disease, COVID19, Coronavirus Disease 2019
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine COVID-19 AntiserumBiological
Also called F(ab)2, BSVEQAb, EqAb-COV-19
Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.
Standard of careDrug
Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided
| Study group | Role | What they receive |
|---|---|---|
| Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care | Experimental | 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 Receives: Biological: Equine COVID-19 Antiserum; Drug: Standard of care |
| Standard of care. | Active comparator | Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: Up to Day 28
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Proportion (percent) of patients turning COVID-19 negative
Measured: Day 5
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)
Proportion (percent) of patients turning COVID-19 negative
Measured: Day 7
Secondary outcomes (17)
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Proportion (percent) of patients patients turning COVID-19 negative
Measured: Day 5
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Proportion (percent) of patients patients turning COVID-19 negative
Measured: Day 7
Phase 1 Exploratory outcome
Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Measured: Day 10
Phase 1 Exploratory outcome
Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative)
Measured: Day 14
Phase 1-Exploratory outcome
Mean reduction in WHO clinical progression scale
Measured: Day 3 from Baseline
Phase 1-Exploratory outcome
Mean reduction in WHO clinical progression scale
Measured: Day 5 from Baseline
Phase 1- Exploratory outcome
Mean reduction in WHO clinical progression scale
Measured: Day 7 from Baseline
Phase 1- Exploratory outcome
Mean reduction in WHO clinical progression scale
Measured: Day 14 from Baseline
Phase 1- Exploratory outcome
Mean reduction in WHO clinical progression scale
Measured: 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
Measured: up to Day 28
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Proportion (percent) of patients turning COVID-19 negative
Measured: Day 10
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Proportion (percent) of patients turning COVID-19 negative
Measured: Day 14
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Measured: Day 3 from baseline
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Measured: Day 5 from baseline
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Measured: Day 7 from baseline
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Measured: Day 14 from baseline
Phase 2 Change in WHO clinical progression scale
Mean reduction in WHO clinical progression scale
Measured: Day 28 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start27 Jul 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Why it stopped: Closed as no eligible patient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. Each patient will receive either of the dose BSVEQAb - 5 mg/kg or 10 mg/kg body weight and all will receive standard of care Based on the results of phase 1 study the phase 2 shall be initiated. In phase 2 study one group will receive the tolerable dose of BSVEQAb selected along with standard of care. The second group will receive only standard of care.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Serums and Vaccines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramesh Jagannathan, Principal investigator, Bharat Serums and Vaccines Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834908
- Sponsor's protocol ID
- BSV_EQ-AB_20_08
- Acronym
- PROTECT
- Status last verified
- Oct 2022
- First submitted
- 23 Mar 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04834908
- Acronym / sponsor ID
- PROTECT / BSV_EQ-AB_20_08
- Conditions
- SARS-CoV-2 Infection
- Keywords
- 2019 Novel Coronavirus Disease, COVID19, Coronavirus Disease 2019
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed as no eligible patient.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bharat Serums and Vaccines LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. Each patient will receive either of the dose BSVEQAb - 5 mg/kg or 10 mg/kg body weight and all will receive standard of care Based on the results of phase 1 study the phase 2 shall be initiated. In phase 2 study one group will receive the tolerable dose of BSVEQAb selected along with standard of care. The second group will receive only standard of care.
| Arm | Type | Receives |
|---|---|---|
| Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care | Experimental | Biological: Equine COVID-19 Antiserum, Drug: Standard of careDose 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 |
| Standard of care. | Active comparator | Drug: Standard of careTreatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age Phase 1: ≥ 18 years to ≤ 55 years Phase 2: ≥ 18 years to ≤ 65 years
- Are male or non-pregnant females who agree to contraceptive requirements.
- Patients with RT-PCR confirmed COVID-19 in ≤ 72 hours prior to randomization [Ct ≥ 24].
- Have SpO2<94% (range 90-93%) on room air.
- Have one or more of the following- dyspnea, fever, cough, respiratory rate ≥ 24 per minute and heart rate up to 120 per minute.
Key exclusion criteria (11 listed)
- Require mechanical ventilation
- Have oxygen saturation less than or equal to 89 percent
- Patients re-infected with SARS-CoV-2
- Suspected or proven serious active bacterial fungal viral or other infection
- Patients with positive skin test with IP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine COVID-19 AntiserumAlso: F(ab)2, BSVEQAb, EqAb-COV-19Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G. | Biological | Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care |
| Standard of careStandard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided | Drug | Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care, Standard of care. |
Primary outcome
Phase 1 Unexpected serious adverse events
Time frame: Up to Day 28
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]
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Time frame: Day 5
Proportion (percent) of patients turning COVID-19 negative
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)
Time frame: Day 7
Proportion (percent) of patients turning COVID-19 negative
17 secondary outcomes
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Time frame: Day 5
Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
Time frame: Day 7
Phase 1 Exploratory outcome
Time frame: Day 10
Phase 1 Exploratory outcome
Time frame: Day 14
Phase 1-Exploratory outcome
Time frame: Day 3 from Baseline
Phase 1-Exploratory outcome
Time frame: Day 5 from Baseline
Phase 1- Exploratory outcome
Time frame: Day 7 from Baseline
Phase 1- Exploratory outcome
Time frame: Day 14 from Baseline
Phase 1- Exploratory outcome
Time frame: Day 28 from Baseline
Phase 2 Unexpected serious adverse events
Time frame: up to Day 28
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Time frame: Day 10
Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
Time frame: Day 14
Phase 2 Change in WHO clinical progression scale
Time frame: Day 3 from baseline
Phase 2 Change in WHO clinical progression scale
Time frame: Day 5 from baseline
Phase 2 Change in WHO clinical progression scale
Time frame: Day 7 from baseline
Phase 2 Change in WHO clinical progression scale
Time frame: Day 14 from baseline
Phase 2 Change in WHO clinical progression scale
Time frame: Day 28 from baseline
Results and safety
The study was stopped early (reason given: Closed as no eligible patient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesh Jagannathan principal investigator
Bharat Serums and Vaccines Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Equine COVID-19 Antiserum in people with SARS-CoV-2 Infection, run by Bharat Serums and Vaccines Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closed as no eligible patient.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Unexpected serious adverse events (time frame: Up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.