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Funding
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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
| Brigham and Women's Hospital | OTHER |
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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 \
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbataceptTreatment Arm | Experimental | Enrolled patients who will receive treatment with abatacept |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | 10mg/kg intravenously administered on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical ventilation-free survival | Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept | 30 days |
| 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% |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacalyn Rosenblatt, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Boston Children's Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| 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 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |