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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04472494
• Collaborator: (none)
• Enrollment: 61
• Locations: 10
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; SARS-CoV-2	Biological: Abatacept; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
• Actual Study Start Date: Oct 14, 2020
• Actual Primary Completion Date: Aug 12, 2021
• Actual Study Completion Date: Sep 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of participants with composite end point of mechanical ventilation or death prior to or on Day 28 [Up to 28 days]

Secondary Outcome Measures

1. Change from baseline in the Ordinal 8-point Outcome Scale on Day 28 [Day 28]

2. All-cause mortality on Day 28 [Day 28]

3. Proportion of participants alive and free of respiratory failure on Day 28 [Day 28]

4. Proportion of participants returned to room air by Day 28 [Up to 28 days]

5. Proportion of participants alive and discharged home by Day 28 [Up to 28 days]

6. Proportion of participants with Serious Adverse Events (SAEs) [Up to 60 days]

7. Proportion of participants with serious infections [Up to 60 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alternative Research Associates, Llc	Hialeah	Florida	United States	33012
2	Alternative Research Associates	Hialeah	Florida	United States	33012
3	Norton Infectious Disease Institute	Louisville	Kentucky	United States	40202
4	Boston Childrens Hospital	Boston	Massachusetts	United States	02115
5	Local Institution - 0002	Boston	Massachusetts	United States	02215
6	Atlantic Health System	Morristown	New Jersey	United States	07960
7	Methodist Health System Clinical Research Institute (MHSCRI)	Dallas	Texas	United States	75203
8	CardioPulmonary Research	Guaynabo		Puerto Rico	00968
9	Ponce Medical School Foundation	Ponce		Puerto Rico	00780
10	Fundacion de Investigacion de Diego	San Juan		Puerto Rico	00927

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04472494
• Other Study ID Numbers: IM101-873; U1111-1250-4217
• First Posted: Jul 15, 2020
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Coronavirus disease 2019 (COVID-19); Coronavirus; Coronavirus infections; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Additional relevant MeSH terms: COVID-19; Abatacept

Study Results

No Results Posted as of Jul 8, 2022