Status:
TERMINATED
ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
Lead Sponsor:
Corewell Health East
Conditions:
COVID-19
Severe Acute Respiratory Syndrome (SARS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when ...
Detailed Description
This trial will evaluate the efficacy and safety of SARS-CoV-2 convalescent plasma as treatment for confirmed COVID-19 respiratory disease (as defined in the inclusion criteria). Participants in both ...
Eligibility Criteria
Inclusion
- Subjects must be 18 years of age or older.
- Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2 Reverse-transcription polymerase chain reaction (RT-PCR) testing.
- Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of breath) at time of screening.
- Patient requires \>6 L nasal cannula oxygen (Group A) or intubated (Group B).
- Patient (or their legal authorized representative) is willing and able to provide written informed consent and comply with all protocol requirements.
Exclusion
- For patients in Group A admitted for \>14 days
- Female subjects with positive pregnancy test, breastfeeding, or planning to become --pregnant or breastfeed during the study period.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
- Patients currently undergoing cancer treatment or those who are presently immunocompromised.
- Patient who in the opinion of the investigator will not be a good study candidate.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2020
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04432272
Start Date
July 16 2020
End Date
November 28 2020
Last Update
March 9 2022
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073