Abatacept for Patients With COVID-19 and Respiratory Distress

NCT04477642 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 2020-P-00XXX
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19

Keywords

Coronavirus

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation-free survival

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

  30 days

Secondary Outcomes (10)

• Duration of days on a ventilator

  30 days

• Days until pulse oxygen is > 93% on room air

  30 days

• Days until supplemental oxygen is no longer required

  30 days

• Duration of fever >= 38°C

  30 days

• Overall survival

  90 days

Study Arms (1)

AbataceptTreatment Arm

EXPERIMENTAL

Enrolled patients who will receive treatment with abatacept

Drug: Abatacept

Interventions

Abatacept DRUG

10mg/kg intravenously administered on Day 1

AbataceptTreatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston Children's Hospital: collaborator
• Bristol-Myers Squibb: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: July 20, 2020
• Study Start: August 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

US (2)