Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial
PhD, MPH Sheriza N Baksh, MD Sonya L Heath, MD Yuriko Fukuta, JD David Shade, MD Barry Meisenberg, MBChB Evan M Bloch, MD, PhD Aaron A R Tobian, MD Emily S Spivak, MD Bela Patel, MD Jonathan Gerber, MD Jay S Raval, MD Donald Forthal, MD James Paxton, MD Giselle Mosnaim, MD Shweta Anjan, MD Janis Blair, MD Edward Cachay, MD, MSc Judith Currier, MS Piyali Das, MD, MSc Moises Huaman, PhD Catherine Sutcliffe, PharmD, MPH Anusha Yarava, MD, PhD Arturo Casadevall, MD David Sullivan, MD Daniel Hanley, MD, MPH Kelly A Gebo
The Journal of Infectious Diseases, doi:10.1093/infdis/jiad023
Background: COVID-19 convalescent plasma (CCP) reduces hospitalizations among outpatients treated early after symptom onset. It is unknown if 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. Additionally, we assessed 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 1,070 outpatients followed after transfusion, 381 of 538 (70.8%) receiving CCP and 381 of 532 (71.6%) receiving control plasma were still symptomatic (p=0.78) at day 14. Associations between CCP and symptom resolution by day 14 were not statistically different from those in controls after adjusting for baseline characteristics (adjusted sub-distribution hazard ratio: 0.99; p=0.62). The most common cluster consisted of cough, fatigue, shortness of breath, and headache, found in 308 (57.2%) and 325 (61.1%) of CCP and control plasma recipients, respectively (p=0.16).
Conclusions: In this trial of outpatients with early COVID-19, CCP was not associated with faster resolution of symptoms compared to control. Overall, there were no differences in the prevalence of each symptom or symptom clusters at day 14 by treatment.
DOI: 10.1093/infdis/jiad023 Disclosures: Dr. Bloch is a member of the FDA's Blood Products Advisory Committee. All opinions in this manuscript are of the authors and do not reflect the Blood Products Advisory Committee or the position of the FDA. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict-of-interest policies. Dr. Casadevall serves on the Scientific Advisory Board of Sabtherapeutics, which is developing cow-derived human immunoglobulins for the treatment of COVID-19 and other infectious diseases. Dr. Gebo is a paid consultant for UptoDate, Teach for America, and the Aspen Institute. No other authors declare a potential conflict of interest.
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'abstract': '<jats:title>Abstract</jats:title>\n'
' <jats:sec>\n'
' <jats:title>Background</jats:title>\n'
' <jats:p>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.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Methods</jats:title>\n'
' <jats:p>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.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Results</jats:title>\n'
' <jats:p>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).</jats:p>\n'
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' <jats:sec>\n'
' <jats:title>Conclusions</jats:title>\n'
' <jats:p>In this trial of outpatients with early COVID-19, CCP was not '
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'differences by treatment in the prevalence of each symptom or symptom clusters at day '
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' </jats:sec>\n'
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' <jats:p>NCT04373460.</jats:p>\n'
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