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

September 13, 2022 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Guaynabo, Puerto Rico, 00968
        • CardioPulmonary Research
      • Ponce, Puerto Rico, 00780
        • Ponce Medical School Foundation
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
    • Florida
      • Hialeah, Florida, United States, 33012
        • Alternative Research Associates, LLC
      • Hialeah, Florida, United States, 33012
        • Alternative Research Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Infectious Disease Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens Hospital
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0002
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Health System Clinical Research Institute (MHSCRI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abatacept + Standard of care
Specified dose on specified days
Other Names:
  • BMS-188667
  • ORENCIA®
Placebo Comparator: Placebo infusion + Standard of care
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first dose to 28 days post first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
Time Frame: Baseline and 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:

  1. Death;
  2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
  3. Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;
  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 Baseline is defined as the last assessment done prior or on Day 1
Baseline and on Day 28
Percentage of Participants Who Died
Time Frame: From first dose to 28 days post first dose

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

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

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

Day 28±3
Percentage of Participants Returned to Room Air on Day 28
Time Frame: 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

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 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

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). 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
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
Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
From first dose to 60 days post first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Actual)

August 12, 2021

Study Completion (Actual)

September 13, 2021

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Placebo

3
Subscribe