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

COVID-19 Clinical Trial

Official title:

Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04472494
• Other study ID #: IM101-873
• Secondary ID: U1111-1250-4217
• Status: Terminated
• Phase: Phase 2
• Start date: October 14, 2020
• Est. completion date: September 13, 2021

Study information

• Verified date: September 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: September 13, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• Abatacept
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Puerto Rico	CardioPulmonary Research	Guaynabo
Puerto Rico	Ponce Medical School Foundation	Ponce
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	Boston Childrens Hospital	Boston	Massachusetts
United States	Local Institution - 0002	Boston	Massachusetts
United States	Methodist Health System Clinical Research Institute (MHSCRI)	Dallas	Texas
United States	Alternative Research Associates	Hialeah	Florida
United States	Alternative Research Associates, Llc	Hialeah	Florida
United States	Norton Infectious Disease Institute	Louisville	Kentucky
United States	Atlantic Health System	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose to 28 days post first dose
Secondary	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	Baseline and on Day 28
Secondary	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	From first dose to 28 days post first dose
Secondary	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	Day 28±3
Secondary	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	Day 28
Secondary	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	From day 1 up to day 28
Secondary	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	From first dose to 60 days post first dose
Secondary	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)	From first dose to 60 days post first dose

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form