NCT04477642

Abatacept for Patients With COVID-19 and Respiratory Distress

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level \</= 93% on room air. The primary endpoint analysis will be performed using all enrolled patients.

Detailed description

Patients with COVID-19 who are admitted with respiratory distress will be considered for enrollment on this study. Patients will be screened and then if they meet eligibility criteria will be enrolled. Abatacept will be administered on Day 1 at a dose of 10 mg/kg. Patients will then be followed closely through 90 days post-treatment.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Abatacept	10mg/kg intravenously administered on Day 1

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2020-07-20
• Last updated: 2020-07-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study