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Abatacept for Patients With COVID-19 and Respiratory Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477642
Recruitment Status : Withdrawn (Funding)
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Collaborators:
Boston Children's Hospital
Bristol-Myers Squibb
Brigham and Women's Hospital
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Abatacept Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abatacept for Patients With COVID-19 and Respiratory Distress
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
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Arm Intervention/treatment
Experimental: AbataceptTreatment Arm
Enrolled patients who will receive treatment with abatacept
 Drug: Abatacept
10mg/kg intravenously administered on Day 1


Outcome Measures
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Primary Outcome Measures :
  1. Mechanical ventilation-free survival [ Time Frame: 30 days ]
    Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept


Secondary Outcome Measures :
  1. Duration of days on a ventilator [ Time Frame: 30 days ]
    Number of days a patient is on a ventilator, if applicable

  2. Days until pulse oxygen is > 93% on room air [ Time Frame: 30 days ]
    Number of days until patient recovers with SpO2 > 93%

  3. Days until supplemental oxygen is no longer required [ Time Frame: 30 days ]
    No supplemental oxygen for at least 24 hours

  4. Duration of fever >= 38°C [ Time Frame: 30 days ]
    Number of days until fever is less than 38°C

  5. Overall survival [ Time Frame: 90 days ]
    Patient survival status through 90 days

  6. Infusion reactions [ Time Frame: 14 days ]
    Number of Infusion Reactions in patients treated with abatacept

  7. Secondary infections [ Time Frame: 90 days ]
    Number of Secondary infections in patients treated with abatacept

  8. Change in Clinical Status, based on 7-point ordinal scale [ Time Frame: 14 days ]
    Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14

  9. Viral load [ Time Frame: 28 days ]
    Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.

  10. Radiographic Improvement [ Time Frame: 14 days ]
    Improvement in lung findings based on CXR (chest x-ray)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477642


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Boston Children's Hospital
Bristol-Myers Squibb
Brigham and Women's Hospital
Investigators
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Principal Investigator: Jacalyn Rosenblatt, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04477642    
Other Study ID Numbers: 2020-P-00XXX
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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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
Keywords provided by Beth Israel Deaconess Medical Center:
Coronavirus
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents