COVID-19Phase 2NCT04472494
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
A Phase 2 study testing Abatacept in people with COVID-19 and SARS-CoV-2, run by Bristol-Myers Squibb at 10 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Abatacept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 14 Oct 2020to 13 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).
- Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)
- Respiratory compromise as defined by requirement of oxygen supplementation to maintain oxygen saturation ≥ 93% but not requiring mechanical ventilation
- Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical condition that would serve as an exclusionary criteria
- Women and men must agree to follow specific methods of contraception, if applicable
Who cannot join
- Women who are breastfeeding
- Recent acute infection defined as:
- Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii) Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy
- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
- Prior exposure to BMS-188667 (abatacept)
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Boston Childrens Hospital
Boston, Massachusetts, 02115
Local Institution - 0002
Boston, Massachusetts, 02215
Methodist Health System Clinical Research Institute (MHSCRI)
Dallas, Texas, 75203
Alternative Research Associates, Llc
Hialeah, Florida, 33012
Alternative Research Associates
Hialeah, Florida, 33012
Norton Infectious Disease Institute
Louisville, Kentucky, 40202
Atlantic Health System
Morristown, New Jersey, 07960
Puerto Rico3 sites
CardioPulmonary Research
Guaynabo, 00968
Ponce Medical School Foundation
Ponce, 00780
Fundacion de Investigacion de Diego
San Juan, 00927
About this study
Official title: Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Abatacept, Placebo
- Keywords
- Coronavirus disease 2019 (COVID-19), Coronavirus, Coronavirus infections, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptBiological
Also called ORENCIA®, BMS-188667
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Abatacept + Standard of care | Experimental | Not described Receives: Biological: Abatacept |
| Placebo infusion + Standard of care | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.
Measured: From first dose to 28 days post first dose
Secondary outcomes (7)
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:
- Death;
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
- Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
- Not hospitalized, limitation on activities and/or requiring home oxygen;
- Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1
Measured: Baseline and on Day 28
Percentage of Participants Who Died
Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
- Death
Measured: From first dose to 28 days post first dose
Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula.
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
- Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
Measured: Day 28±3
Percentage of Participants Returned to Room Air on Day 28
Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge.
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities
Measured: Day 28
Percentage of Participants Alive and Discharged From the Hospital by Day 28
Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
- Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
Measured: From day 1 up to day 28
Percentage of Participants With Serious Adverse Events
Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:
- Results in death
- Is life threatening
- Requires inpatient hospitalization
- Results in persistent or significant disability
- Is a congenital anomaly/birth defect
- Is an important medical event
Measured: From first dose to 60 days post first dose
Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
Measured: From first dose to 60 days post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start14 Oct 2020
- Primary completion12 Aug 2021
- Study completion13 Sep 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472494
- Sponsor's protocol ID
- IM101-873
- Other IDs
- U1111-1250-4217
- Status last verified
- Sep 2022
- First submitted
- 14 Jul 2020
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
- ClinicalTrials.gov ID
- NCT04472494
- Acronym / sponsor ID
- IM101-873
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- Coronavirus disease 2019 (COVID-19), Coronavirus, Coronavirus infections, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Posted 7 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept + Standard of care | Experimental | Biological: Abatacept |
| Placebo infusion + Standard of care | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).
- Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)
- Respiratory compromise as defined by requirement of oxygen supplementation to maintain oxygen saturation ≥ 93% but not requiring mechanical ventilation
- Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical condition that would serve as an exclusionary criteria
- Women and men must agree to follow specific methods of contraception, if applicable
Key exclusion criteria (6 listed)
- Women who are breastfeeding
- Recent acute infection defined as:
- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
- Prior exposure to BMS-188667 (abatacept)
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| AbataceptAlso: ORENCIA®, BMS-188667Specified dose on specified days | Biological | Abatacept + Standard of care |
| PlaceboSpecified dose on specified days | Other | Placebo infusion + Standard of care |
Primary outcome
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
Time frame: From first dose to 28 days post first dose
The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.
7 secondary outcomes
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
Time frame: Baseline and on Day 28
Percentage of Participants Who Died
Time frame: From first dose to 28 days post first dose
Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
Time frame: Day 28±3
Percentage of Participants Returned to Room Air on Day 28
Time frame: Day 28
Percentage of Participants Alive and Discharged From the Hospital by Day 28
Time frame: From day 1 up to day 28
Percentage of Participants With Serious Adverse Events
Time frame: From first dose to 60 days post first dose
Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
Time frame: From first dose to 60 days post first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with COVID-19 and SARS-CoV-2, run by Bristol-Myers Squibb at 10 sites in 2 countries.
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 5 inclusion and 6 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 7 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 10 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 7 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28 (time frame: From first dose to 28 days post first dose). 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 7 Oct 2022.