Status:
COMPLETED
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
Lead Sponsor:
University of Pennsylvania
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused b...
Detailed Description
This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study ...
Eligibility Criteria
Inclusion
- Adult ≥18 years of age
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.
- Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.
- Hospitalized in participating facility.
- Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
- Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:
- Room air saturation of oxygen (SaO2) \< 93%, OR
- Requiring supplemental oxygen, OR
- Tachypnea with respiratory rate ≥30
- Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements
Exclusion
- Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
- Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
- Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04397757
Start Date
May 13 2020
End Date
March 8 2021
Last Update
April 19 2022
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104