Clinical trial
CSP #2030 - Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Name
2030
Description
The purpose of this study is to assess whether convalescent plasma therapy is associated with reduced 30-day all-cause mortality in a population of Veteran inpatients with non-severe coronavirus disease 2019 (COVID-19).
Trial arms
Trial start
2020-05-01
Estimated PCD
2021-10-01
Trial end
2021-10-01
Status
Completed
Treatment
COVID-19 convalescent plasma
Convalescent plasma collected from individuals who have recovered from COVID-19
Arms:
Exposed
Size
5044
Primary endpoint
All-cause Mortality
30 days
Eligibility criteria
Inclusion Criteria:
* US Veterans aged 21-80 years old
* Hospitalized between May 1, 2020 and November 17, 2020 with a SARS-CoV-2 positive test, at a VA Medical Center where convalescent plasma had been administered to at least one patient and remained a current practice at that VA Medical Center
* SARS-CoV-2 positive test within 7 days before or after hospital admission
* Minimum oxygen saturation (measured within the past day) \>=90%
* Vitals (pulse, respiration, temperature, systolic blood pressure) and acute labs (hemoglobin, platelet, white blood cells) measured within the past 2 days
* Albumin, Alanine Aminotransferase (ALT), creatinine measured within the past 30 days
* Weight measurement recorded in the past 2 years
Exclusion Criteria:
* Prior intubation, ventilation, high flow oxygen, extracorporeal membrane oxygenation (ECMO), dialysis, or vasopressors during current hospitalization
* Record of prior treatment with CP
* Received long-term care in a domiciliary or nursing home in the past 90 days
* First CP recipient at a site
* Less than 30 days of follow-up
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biospecimens will be collected'}, 'enrollmentInfo': {'count': 5044, 'type': 'ACTUAL'}}
Updated at
2024-04-04
1 organization
1 product
1 indication
Organization
VA Office of Research and DevelopmentProduct
COVID-19 convalescent plasmaIndication
COVID-19