COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04472494

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Clinical.Trials@bms.com

2020-07-15

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

- 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

2

Bristol-Myers Squibb

18

100

Puerto Rico;United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

61

Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28

None

Phase 2

[{"arm_notes": "", "treatment_id": 6, "treatment_name": "Abatacept", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]