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All Studies   All Outcomes    Recent:   
0 0.5 1 1.5 2+ Recovery -1% Improvement Relative Risk Conv. Plasma  CSSC-004  LATE TREATMENT  DB RCT Is late treatment with convalescent plasma beneficial for COVID-19? Double-blind RCT 1,070 patients in the USA (June 2020 - October 2021) No significant difference in recovery c19early.org Baksh et al., The J. Infectious Diseases, Jan 2023 Favors conv. plasma Favors control

Symptom duration and resolution with early outpatient treatment of convalescent plasma for COVID- 19: a randomized trial

Baksh et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiad023, CSSC-004, NCT04373460
Jan 2023  
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RCT 1,070 outpatients in the USA, showing no significant difference in recovery with convalescent plasma treatment.
risk of no recovery, 1.0% higher, RR 1.01, p = 0.62, treatment 381 of 538 (70.8%), control 381 of 532 (71.6%), NNT 125, inverted to make RR<1 favor treatment, day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Baksh et al., 31 Jan 2023, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 26 authors, study period 3 June, 2020 - 1 October, 2021, average treatment delay 6.0 days, trial NCT04373460 (history) (CSSC-004).
This PaperConv. PlasmaAll
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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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' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Clinical Trials Registration</jats:title>\n' ' <jats:p>NCT04373460.</jats:p>\n' ' </jats:sec>', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-8341-860X', 'affiliation': [ { 'name': 'Department of Epidemiology Bloomberg Johns Hopkins School of ' 'Public Health , Baltimore, Maryland , USA'}], 'authenticated-orcid': False, 'family': 'Baksh', 'given': 'Sheriza N', 'sequence': 'first'}, { 'affiliation': [ { 'name': 'Department of Medicine, Division of Infectious Diseases, ' 'University of Alabama at Birmingham , Birmingham, Alabama , ' 'USA'}], 'family': 'Heath', 'given': 'Sonya L', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Department of Medicine, Section of Infectious Diseases, Baylor ' 'College of Medicine , Houston, Texas , USA'}], 'family': 'Fukuta', 'given': 'Yuriko', 'sequence': 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'385', 'year': '2021'}, { 'DOI': '10.1056/NEJMoa2103784', 'article-title': 'Early convalescent plasma for high-risk outpatients with Covid-19', 'author': 'Korley', 'doi-asserted-by': 'crossref', 'first-page': '1951', 'journal-title': 'N Engl J Med', 'key': '2023052916412439000_jiad023-B20', 'volume': '385', 'year': '2021'}, { 'DOI': '10.1056/NEJMoa2033700', 'article-title': 'Early high-titer plasma therapy to prevent severe Covid-19 in older ' 'adults', 'author': 'Libster', 'doi-asserted-by': 'crossref', 'first-page': '610', 'journal-title': 'N Engl J Med', 'key': '2023052916412439000_jiad023-B21', 'volume': '384', 'year': '2021'}, { 'DOI': '10.1056/NEJMoa2102685', 'article-title': 'Bamlanivimab plus etesevimab in mild or moderate Covid-19', 'author': 'Dougan', 'doi-asserted-by': 'crossref', 'first-page': '1382', 'journal-title': 'N Engl J Med', 'key': '2023052916412439000_jiad023-B22', 'volume': '385', 'year': '2021'}, { 'DOI': '10.1101/2022.03.10.22272100', 'article-title': 'Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a ' 'broadly neutralizing monoclonal antibody treatment for mild to ' 'moderate, ambulatory COVID-19', 'author': 'Dougan', 'doi-asserted-by': 'crossref', 'key': '2023052916412439000_jiad023-B23', 'volume-title': 'medRxiv'}, { 'author': 'U.S. Food and Drug Administration', 'key': '2023052916412439000_jiad023-B24', 'year': '2021'}], 'reference-count': 24, 'references-count': 24, 'relation': {}, 'resource': {'primary': {'URL': 'https://academic.oup.com/jid/article/227/11/1266/7017764'}}, 'score': 1, 'short-title': [], 'source': 'Crossref', 'subject': ['Infectious Diseases', 'Immunology and Allergy'], 'subtitle': [], 'title': 'Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for ' 'Coronavirus Disease 2019: A Randomized Trial', 'type': 'journal-article', 'volume': '227'}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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