8/23/2021 | 11:45 AM to 1:30 PM
Convalescent Plasma Therapy and Mortality Among US Veterans Hospitalized with Non-severe COVID-19: An Observational Analysis Emulating a Target Trial
Objectives: To determine if early treatment with convalescent plasma reduces 30-day mortality among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive Veterans hospitalized at a Department of Veterans Affairs (VA) facility with non-severe disease.
Methods: We emulated a hypothetical target trial using observational data from the VA electronic health record database. Patients would be eligible for the target trial if they were admitted to a VA Medical Center between May 1 and November 17, 2020, with a SARS-CoV-2 positive test within 7 days of admission. Additional eligibility criteria included age (21-80 years), no prior plasma treatment, no long-term care within 90 days, an oxygen saturation of ≥90% within the past day, and non-severe disease. The intervention of convalescent plasma would be administered within 2 days of first eligibility. The emulation analysis fit inverse probability weighted pooled logistic models to estimate the observational analogue of the per-protocol effect of convalescent plasma on risk of 30-day mortality.
Results: The 4,755 eligible patients were enrolled in 11,269 person-trials (93% male; 57% white; mean age 64±12 years). Over 2,000 patients received convalescent plasma therapy at a VA medical center, but only 402 met the eligibility criteria. Compared with the non-plasma group, the plasma group was more likely to have comorbidities; have had an intensive care unit admission; have received glucocorticoid or remdesivir treatment; have higher white blood cell counts; and have lower oxygen saturation levels. Among the plasma trials and non-plasma trials, 40 and 671 deaths occurred, respectively. The estimated 30-day mortality risk was 6.46% (95% CI: 4.06, 9.85) and 6.28% (95% CI: 5.77, 6.85) in the plasma and non-plasma groups, respectively, corresponding to a risk difference of 0.30% (95% CI -2.19–3.66) and hazard ratio of 1.04 (95% CI: 0.61–1.60).
Conclusions: Most plasma patients hospitalized within VA were not treated early in the disease course, as recommended under current emergency use authorization. However, no difference in 30-day mortality was observed between patients with non-severe COVID-19 who received convalescent plasma early and those untreated with plasma. Further research is necessary to examine the effect of convalescent plasma on progression to severe disease and the effective plasma dose.
Authors
Speakers
Katherine Kurgansky
Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System
Kelly Cho
MAVERIC, VA Boston Healthcare System
Sarah Keithly
Seattle Epidemiologic Research and Information Center; VA Healthcare System
Arin Madenci
Harvard T.H. Chan School of Public Health
Hanna Gerlovin
MAVERIC; VA Boston Healthcare System
Helen Wellman
MAVERIC; VA Boston Healthcare System
Annie Doubleday
Seattle Epidemiologic Research and Information Center; VA Healthcare System
Eva Thomas
Seattle Epidemiologic Research and Information Center; VA Healthcare System
Yojin Park
MAVERIC; VA Boston Healthcare system
Yuk-Lam Ho
Data Analyst VA Boston Healthcare System
Jonathan Sugimoto
Seattle Epidemiologic Research and Information Center; VA Healthcare System
Kathryn Moore
Seattle Epidemiologic Research and Information Center; VA Healthcare System
Alexander Peterson
Seattle Epidemiologic Research and Information Center; VA Healthcare System
Constance Hoag
MAVERIC; VA Boston Healthcare system
Kalpana Gupta
Veterans Administration Boston Healthcare System
Karen Jeans
Department of Veterans Affairs Office of Research and Development
Molly Klote
Department of Veterans Affairs Office of Research and Development
Rachel Ramoni
Department of Veterans Affairs Office of Research and Development
Grant Huang
Department of Veterans Affairs Office of Research and Development
Juan Casas
MAVERIC; VA Boston Healthcare System
David Gagnon
MAVERIC; VA Boston Healthcare System
Miguel Hernán
Departments of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health
Nicholas Smith
Seattle Epidemiologic Research and Information Center, Department of Veterans Affairs
J Michael Gaziano
MAVERIC; VA Boston Healthcare System
COVID-19 Epidemiology: Risk Factors, Drug Exposures, and Outcomes
Category
General Sessions
Description
Presenting Author
Katherine Kurgansky
| Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System