Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial

Sheriza N Baksh; Sonya L Heath; Yuriko Fukuta; David Shade; Barry Meisenberg; Evan M Bloch; Aaron A R Tobian; Emily S Spivak; Bela Patel; Jonathan Gerber; Jay S Raval; Donald Forthal; James Paxton; Giselle Mosnaim; Shweta Anjan; Janis Blair; Edward Cachay; Judith Currier; Piyali Das; Moises Huaman; Catherine Sutcliffe; Anusha Yarava; Arturo Casadevall; David Sullivan; Daniel Hanley; Kelly A Gebo

doi:10.1093/infdis/jiad023

Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial

J Infect Dis. 2023 May 29;227(11):1266-1273. doi: 10.1093/infdis/jiad023.

Authors

Sheriza N Baksh¹, Sonya L Heath², Yuriko Fukuta³, David Shade¹, Barry Meisenberg⁴, Evan M Bloch⁵, Aaron A R Tobian⁵, Emily S Spivak⁶, Bela Patel⁷, Jonathan Gerber⁸, Jay S Raval⁹, Donald Forthal¹⁰, James Paxton¹¹, Giselle Mosnaim¹², Shweta Anjan¹³, Janis Blair¹⁴, Edward Cachay¹⁵, Judith Currier¹⁶, Piyali Das¹⁷, Moises Huaman¹⁸, Catherine Sutcliffe¹, Anusha Yarava¹⁷, Arturo Casadevall¹⁹, David Sullivan¹⁹, Daniel Hanley¹⁷, Kelly A Gebo²⁰

Affiliations

¹ Department of Epidemiology Bloomberg Johns Hopkins School of Public Health, Baltimore, Maryland, USA.
² Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.
³ Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA.
⁴ Department of Medicine and Research Institute of Luminis Health, Annapolis, Maryland, USA.
⁵ Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁶ Department of Medicine, Division of Infectious Diseases, University of Utah, Salt Lake City, Utah, USA.
⁷ Department of Medicine, Divisions of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, Texas, USA.
⁸ Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, Massachusetts, USA.
⁹ Department of Pathology, University of New Mexico, Albuquerque, New Mexico, USA.
¹⁰ Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, California, USA.
¹¹ Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.
¹² Department of Medicine Northshore University Health System, Division of Allergy and Immunology, Evanston, Illinois, USA.
¹³ Department of Medicine, Division of Infectious Diseases, University of Miami, Miami, Florida, USA.
¹⁴ Department of Medicine, Division of Infectious Diseases, Mayo Clinic, Phoenix, Phoenix, Arizona, USA.
¹⁵ Department of Medicine, Division of Infectious Diseases, University of California, San Diego, La Jolla, California, USA.
¹⁶ Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA.
¹⁷ Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹⁸ Department of Medicine, Division of Infectious Diseases, University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
¹⁹ Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
²⁰ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Abstract

Background: Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) reduces hospitalizations among outpatients treated early after symptom onset. It is unknown whether CCP reduces time to symptom resolution among outpatients.

Methods: We evaluated symptom resolution at day 14 by trial arm using an adjusted subdistribution hazard model, with hospitalization as a competing risk. We also assessed the prevalence of symptom clusters at day 14 between treatments. Clusters were defined based on biologic clustering, impact on ability to work, and an algorithm.

Results: Among 1070 outpatients followed up after transfusion, 381 of 538 (70.8%) receiving CCP and 381 of 532 (71.6%) receiving control plasma were still symptomatic (P = .78) at day 14. Associations between CCP and symptom resolution by day 14 did not differ significantly from those in controls after adjustment for baseline characteristics (adjusted subdistribution hazard ratio, 0.99; P = .62). The most common cluster consisted of cough, fatigue, shortness of breath, and headache and was found in 308 (57.2%) and 325 (61.1%) of CCP and control plasma recipients, respectively (P = .16).

Conclusions: In this trial of outpatients with early COVID-19, CCP was not associated with faster resolution of symptoms compared with control. Overall, there were no differences by treatment in the prevalence of each symptom or symptom clusters at day 14.

Clinical trials registration: NCT04373460.

Keywords: COVID-19; COVID-19 serotherapy; plasma; symptom duration.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Intramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, N.I.H., Extramural

MeSH terms

COVID-19 Serotherapy
COVID-19* / therapy
Humans
Immunization, Passive / adverse effects
Outpatients
SARS-CoV-2
Syndrome

Associated data

ClinicalTrials.gov/NCT04373460

Abstract

Publication types

MeSH terms

Associated data

Grants and funding