Status:
COMPLETED
The COVID-19 PUI Reality Check (CPRC) Study
Lead Sponsor:
Bassett Healthcare
Collaborating Sponsors:
Bioreference, Inc
Conditions:
Covid19 Immunology
Eligibility:
All Genders
18+ years
Brief Summary
This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons bei...
Detailed Description
This is essentially a two phase blood drawing and immune assays study. Phase 1 will be a single convalescent timing immune retrospective study; phase 2 will include paired samples to increase immune r...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Hospitalized patient (PUI or APS) and tested for SARS-CoV-2 by NP PCR swab
- At least one negative SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
- Adult \>/= 18 yrs old
- Patient or LAR provides informed consent
- Patient or LAR agree to follow-up procedures in informed consent form
- Exclusion criteria:
- Prior reaction to blood drawing considered significant safety issue by study investigator
- Other factor considered significant safety issue by study investigator
- At least one positive SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
Exclusion
Key Trial Info
Start Date :
July 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04474288
Start Date
July 16 2020
End Date
February 28 2022
Last Update
March 11 2022
Active Locations (1)
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1
Bassett Medical Center
Cooperstown, New York, United States, 13326