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Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

Primary Purpose

COVID-19, SARS-CoV-2

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abatacept
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus disease 2019 (COVID-19), Coronavirus, Coronavirus infections, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women who are breastfeeding

  • Recent acute infection defined as:

    i) 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

Sites / Locations

  • Alternative Research Associates, Llc
  • Alternative Research Associates
  • Norton Infectious Disease Institute
  • Boston Childrens Hospital
  • Local Institution - 0002
  • Atlantic Health System
  • Methodist Health System Clinical Research Institute (MHSCRI)
  • CardioPulmonary Research
  • Ponce Medical School Foundation
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abatacept + Standard of care

Placebo infusion + Standard of care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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: 1) Death
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: 4) 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
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: 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; 8) Not hospitalized, no limitation on activities
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: 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
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
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)

Full Information

First Posted
July 14, 2020
Last Updated
September 13, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04472494
Brief Title
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Official Title
Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
Coronavirus disease 2019 (COVID-19), Coronavirus, Coronavirus infections, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abatacept + Standard of care
Arm Type
Experimental
Arm Title
Placebo infusion + Standard of care
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Abatacept
Other Intervention Name(s)
ORENCIA®, BMS-188667
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
Description
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.
Time Frame
From first dose to 28 days post first dose
Secondary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
Description
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
Time Frame
Baseline and on Day 28
Title
Percentage of Participants Who Died
Description
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: 1) Death
Time Frame
From first dose to 28 days post first dose
Title
Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
Description
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: 4) 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
Time Frame
Day 28±3
Title
Percentage of Participants Returned to Room Air on Day 28
Description
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: 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; 8) Not hospitalized, no limitation on activities
Time Frame
Day 28
Title
Percentage of Participants Alive and Discharged From the Hospital by Day 28
Description
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: 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
Time Frame
From day 1 up to day 28
Title
Percentage of Participants With Serious Adverse Events
Description
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
Time Frame
From first dose to 60 days post first dose
Title
Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
Description
Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
Time Frame
From first dose to 60 days post first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Women who are breastfeeding Recent acute infection defined as: i) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Alternative Research Associates, Llc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Alternative Research Associates
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Norton Infectious Disease Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Boston Childrens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Local Institution - 0002
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Methodist Health System Clinical Research Institute (MHSCRI)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
CardioPulmonary Research
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Facility Name
Ponce Medical School Foundation
City
Ponce
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

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