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

Indication
COVID-19