Abatacept for Patients With COVID-19 and Respiratory Distress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AbataceptTreatment Arm

Enrolled patients who will receive treatment with abatacept

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

10mg/kg intravenously administered on Day 1

Interventions

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Abatacept

10mg/kg intravenously administered on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be at least 18 years old.
* Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) \</=4 days prior to enrollment
* Evidence of respiratory distress including SpO2 \</=93% on room air.
* Radiographic evidence of pulmonary infiltrates.
* Ability to understand and the willingness to provide informed consent.

Exclusion Criteria

* Patients already intubated/mechanically ventilated at screening will not be eligible.
* Patients with uncontrolled severe bacterial or fungal infections at the time of enrollment.
* Patients with previously diagnosed autoimmune disorders or who were on immunosuppressive medications prior to developing COVID-19 are not eligible
* Pregnant or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No