Abatacept for Patients With COVID-19 and Respiratory Distress

Beth Israel Deaconess Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

COVID-19

Interventions

AbataceptDRUG

10mg/kg intravenously administered on Day 1

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Mechanical ventilation-free survival

Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept

Time frame: 30 days

Secondary Outcomes

Duration of days on a ventilator

Number of days a patient is on a ventilator, if applicable

Time frame: 30 days

Days until pulse oxygen is > 93% on room air

Number of days until patient recovers with SpO2 \> 93%

Time frame: 30 days

Days until supplemental oxygen is no longer required

No supplemental oxygen for at least 24 hours

Time frame: 30 days

Duration of fever >= 38°C

Number of days until fever is less than 38°C

Time frame: 30 days

Overall survival

Patient survival status through 90 days

Time frame: 90 days

Infusion reactions

Number of Infusion Reactions in patients treated with abatacept

Time frame: 14 days

Secondary infections

Number of Secondary infections in patients treated with abatacept

Time frame: 90 days

Change in Clinical Status, based on 7-point ordinal scale

Data from ClinicalTrials.gov

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