1. A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia
- Author
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James D. Gordon, Kathleen O. Degnan, Leah Irwin, Don L. Siegel, Maria Caturla, Ian Frank, Andrew D. Fesnak, Raeann Thomas, Pamela A. Shaw, Sigrid Gouma, Holly Barilla, Miranda Mastellone, Nicole A. Aqui, M. Alexandra Monroy, Anne M Mullin, Marie Buchanan, Eline T. Luning Prak, Maureen DeMarshall, Risa A Eichinger, Pablo Tebas, Geoff Feret, Michal A. Elovitz, Katharine J. Bar, Faye Demuth, William R. Short, Jose L. Pascual, Haideliza Soto-Calderon, Julie Starr, Felicity Mampe, Jasper B Yang, Scott E. Hensley, Nuala J. Meyer, Alan Wanicur, Anastasiya Pronina, Chigozie Amonu, Michelle Andronov, Jillian Baron, Grace H Choi, Lizette Grajales, and Emily Lindemuth
- Subjects
Adult ,Male ,medicine.medical_specialty ,Convalescent plasma ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,medicine.medical_treatment ,Pneumonia, Viral ,Antibodies, Viral ,law.invention ,Randomized controlled trial ,Risk Factors ,law ,Internal medicine ,Immune Tolerance ,medicine ,Humans ,COVID-19 Serotherapy ,Aged ,Immunosuppression Therapy ,Mechanical ventilation ,SARS-CoV-2 ,business.industry ,Incidence ,Immunization, Passive ,COVID-19 ,Immunosuppression ,General Medicine ,Middle Aged ,medicine.disease ,Respiration, Artificial ,Hospitalization ,Oxygen ,Clinical trial ,Pneumonia ,Treatment Outcome ,RNA, Viral ,Female ,Clinical Medicine ,business - Abstract
BACKGROUND: Antibody-based strategies for COVID-19 have shown promise in prevention and treatment of early disease. COVID-19 convalescent plasma (CCP) has been widely used but results from randomized trials supporting its benefit in hospitalized patients with pneumonia are limited. Here, we assess the efficacy of CCP in severely ill, hospitalized adults with COVID-19 pneumonia. METHODS: We performed a randomized control trial (PennCCP2), with 80 adults hospitalized with COVID-19 pneumonia, comparing up to 2 units of locally sourced CCP plus standard care versus standard care alone. The primary efficacy endpoint was comparison of a clinical severity score. Key secondary outcomes include 14- and 28-day mortality, 14- and 28-day maximum 8-point WHO ordinal score (WHO8) score, duration of supplemental oxygenation or mechanical ventilation, respiratory SARS-CoV-2 RNA, and anti–SARS-CoV-2 antibodies. RESULTS: Eighty hospitalized adults with confirmed COVID-19 pneumonia were enrolled at median day 6 of symptoms and day 1 of hospitalization; 60% were anti–SARS-CoV-2 antibody seronegative. Participants had a median of 3 comorbidities, including risk factors for severe COVID-19 and immunosuppression. CCP treatment was safe and conferred significant benefit by clinical severity score (median [MED] and interquartile range [IQR] 10 [5.5–30] vs. 7 [2.75–12.25], P = 0.037) and 28-day mortality (n = 10, 26% vs. n = 2, 5%; P = 0.013). All other prespecified outcome measures showed weak evidence toward benefit of CCP. CONCLUSION: Two units of locally sourced CCP administered early in hospitalization to majority seronegative participants conferred a significant benefit in clinical severity score and 28-day mortality. Results suggest CCP may benefit select populations, especially those with comorbidities who are treated early. TRIAL REGISTRATION: ClinicalTrials.gov NCT04397757. FUNDING: University of Pennsylvania.
- Published
- 2021