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

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19)
• Interventions: Biological: COVID-19 convalescent plasma

• Registration Number: NCT04545047
• Lead Sponsor: VA Office of Research and Development

Brief 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).

Detailed Description

The convalescent plasma (CP) of individuals who have recovered from COVID-19 may help reduce symptoms and mortality when given to ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical trials are needed to provide definitive evidence of the benefits and harms of CP in the treatment of COVID-19. While clinical trials are underway, observational research plays a critical role in providing preliminary scientific evidence to guide clinical practice.

This observational study aims to estimate the association between CP therapy and mortality after 30 days in a sample of SARS-CoV-2-positive patients with non-severe illness. Patients include those hospitalized at a facility within the Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA), the largest integrated healthcare system in the United States. Using VA electronic health record data, the study is designed to emulate a target trial of convalescent plasma transfusion and mortality. The primary exposure of interest is the use or non-use of COVID-19 convalescent plasma, and the primary outcome is 30-day all-cause mortality.

A nested trial design will be used, in which patients will be followed from each day in which eligibility criteria are met (while hospitalized and after date of first positive SARS-CoV-2 test) for 30 days. The association between CP therapy and mortality will be assessed using pooled logistic models to estimate 30-day cumulative incidence curves, risk differences, and hazard ratios. Inverse probability weighting derived from propensity scores will be employed to minimize confounding by indication and other biases.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Results First Submitted: 2022-09-14
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Results First Posted: 2024-04-04
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5044

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	COVID-19 convalescent plasma	Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	30 days	Death at 30 days recorded in the electronic health record. Follow-up starts at the treatment date, which must be within 2 days after both hospitalization and SARS-CoV-2-positive test, and ends at 30 days or death.

Trial Locations

Locations (2)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States