Abatacept for Patients With COVID-19 and Respiratory Distress
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|ClinicalTrials.gov Identifier: NCT04477642|
Recruitment Status : Withdrawn (Funding)
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Abatacept||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: AbataceptTreatment Arm
Enrolled patients who will receive treatment with abatacept
10mg/kg intravenously administered on Day 1
- Mechanical ventilation-free survival [ Time Frame: 30 days ]Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept
- Duration of days on a ventilator [ Time Frame: 30 days ]Number of days a patient is on a ventilator, if applicable
- Days until pulse oxygen is > 93% on room air [ Time Frame: 30 days ]Number of days until patient recovers with SpO2 > 93%
- Days until supplemental oxygen is no longer required [ Time Frame: 30 days ]No supplemental oxygen for at least 24 hours
- Duration of fever >= 38°C [ Time Frame: 30 days ]Number of days until fever is less than 38°C
- Overall survival [ Time Frame: 90 days ]Patient survival status through 90 days
- Infusion reactions [ Time Frame: 14 days ]Number of Infusion Reactions in patients treated with abatacept
- Secondary infections [ Time Frame: 90 days ]Number of Secondary infections in patients treated with abatacept
- 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
- 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.
- Radiographic Improvement [ Time Frame: 14 days ]Improvement in lung findings based on CXR (chest x-ray)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jacalyn Rosenblatt, MD||Beth Israel Deaconess Medical Center|
|Responsible Party:||Beth Israel Deaconess Medical Center|
|Other Study ID Numbers:||
|First Posted:||July 20, 2020 Key Record Dates|
|Last Update Posted:||July 20, 2020|
|Last Verified:||July 2020|
|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|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Physiological Effects of Drugs