Abatacept for Patients With COVID-19 and Respiratory Distress

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Drug: Abatacept

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AbataceptTreatment Arm; Enrolled patients who will receive treatment with abatacept	Drug: Abatacept; 10mg/kg intravenously administered on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilation-free survival	Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of days on a ventilator	Number of days a patient is on a ventilator, if applicable	30 days
Days until pulse oxygen is > 93% on room air	Number of days until patient recovers with SpO2 > 93%	30 days
Days until supplemental oxygen is no longer required	No supplemental oxygen for at least 24 hours	30 days
Duration of fever >= 38°C	Number of days until fever is less than 38°C	30 days
Overall survival	Patient survival status through 90 days	90 days
Infusion reactions	Number of Infusion Reactions in patients treated with abatacept	14 days
Secondary infections	Number of Secondary infections in patients treated with abatacept	90 days
Change in Clinical Status, based on 7-point ordinal scale	Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14	14 days
Viral load	Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.	28 days
Radiographic Improvement	Improvement in lung findings based on CXR (chest x-ray)	14 days

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Bristol-Myers Squibb; Boston Children's Hospital; Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: 2020-P-00XXX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No