Status:
COMPLETED
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
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 can improve patients' health when they are sick with COVID-19.
Detailed Description
This open-label, single arm, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study w...
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, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
- Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
- 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. a. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04388527
Start Date
April 30 2020
End Date
January 30 2021
Last Update
April 4 2022
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104