Status:
COMPLETED
COVID-19 Convalescent Plasma
Lead Sponsor:
University of Chicago
Conditions:
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, the...
Eligibility Criteria
Inclusion
- Donor
- Age greater or equal to 18
- Able to donate blood per blood bank standard guidelines
- Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
- Complete resolution of symptoms at least 28 days prior to donation
- Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors
- Donor
Exclusion
- Does not provide consent
- Does not meet standard blood bank donation guidelines
- Unsuccessful blood donation
- Recipient Inclusion Criteria:
- Patients must be 18 years of age or older
- Must have laboratory-confirmed COVID-19
- Must have severe or immediately life-threatening COVID-19
- Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or lung infiltrates \> 50% within 24 to 48 hours
- Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
- Must be less than 21 days from the start of illness
- Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
- Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
- Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma
- Recipient
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04340050
Start Date
April 10 2020
End Date
December 23 2020
Last Update
February 28 2024
Active Locations (1)
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1
University of Chicago Medicine
Chicago, Illinois, United States, 60637