Clinical trial NCT04472494: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
SARS-CoV-2
Keywords: Coronavirus disease 2019 (COVID-19)
Coronavirus
Coronavirus infections
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
timeFrame: From first dose to 28 days post first dose
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
timeFrame: Baseline and on Day 28
measure: Percentage of Participants Who Died
timeFrame: From first dose to 28 days post first dose
measure: Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
timeFrame: Day 28±3
measure: Percentage of Participants Returned to Room Air on Day 28
timeFrame: Day 28
measure: Percentage of Participants Alive and Discharged From the Hospital by Day 28
timeFrame: From day 1 up to day 28
measure: Percentage of Participants With Serious Adverse Events
timeFrame: From first dose to 60 days post first dose
measure: Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
timeFrame: From first dose to 60 days post first dose
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Alternative Research Associates, Llc
state: Florida
city: Hialeah
country: United States
facility: Alternative Research Associates
state: Florida
city: Louisville
country: United States
facility: Norton Infectious Disease Institute
state: Kentucky
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0002
state: Massachusetts
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Dallas
country: United States
facility: Methodist Health System Clinical Research Institute (MHSCRI)
state: Texas
city: Guaynabo
country: Puerto Rico
facility: CardioPulmonary Research
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: