N/A N=5,044

Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19

Coronavirus Disease 2019 (COVID-19)

Bottom Line

View on ClinicalTrials.gov: NCT04545047 ↗

Enrolled (actual)

5,044

Serious AEs

—

Results posted

Apr 2024

Primary outcome: Primary: All-cause Mortality — 40; 671 Person-trials

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: COVID-19 convalescent plasma (Biological)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY All-cause Mortality	40; 671	—

Summary

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04545047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.