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Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.
Axfors, Cathrine; Janiaud, Perrine; Schmitt, Andreas M; Van't Hooft, Janneke; Smith, Emily R; Haber, Noah A; Abayomi, Akin; Abduljalil, Manal; Abdulrahman, Abdulkarim; Acosta-Ampudia, Yeny; Aguilar-Guisado, Manuela; Al-Beidh, Farah; Alejandria, Marissa M; Alfonso, Rachelle N; Ali, Mohammad; AlQahtani, Manaf; AlZamrooni, Alaa; Anaya, Juan-Manuel; Ang, Mark Angelo C; Aomar, Ismael F; Argumanis, Luis E; Averyanov, Alexander; Baklaushev, Vladimir P; Balionis, Olga; Benfield, Thomas; Berry, Scott; Birocco, Nadia; Bonifacio, Lynn B; Bowen, Asha C; Bown, Abbie; Cabello-Gutierrez, Carlos; Camacho, Bernardo; Camacho-Ortiz, Adrian; Campbell-Lee, Sally; Cao, Damon H; Cardesa, Ana; Carnate, Jose M; Castillo, German Jr J; Cavallo, Rossana; Chowdhury, Fazle R; Chowdhury, Forhad U H; Ciccone, Giovannino; Cingolani, Antonella; Climacosa, Fresthel Monica M; Compernolle, Veerle; Cortez, Carlo Francisco N; Costa Neto, Abel; D'Antico, Sergio; Daly, James; Danielle, Franca.
  • Axfors C; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, USA.
  • Janiaud P; Department for Women's and Children's Health, Uppsala University, Uppsala, Sweden.
  • Schmitt AM; Department of Clinical Research, University Hospital Basel, University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
  • Van't Hooft J; Department of Clinical Research, University Hospital Basel, University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
  • Smith ER; Department of Medical Oncology, University of Basel, Basel, Switzerland.
  • Haber NA; Amsterdam University Medical Center, Amsterdam University, Amsterdam, The Netherlands.
  • Abayomi A; Department of Global Health, Milken Institute School of Public Health, The George Washington University, Washington, USA.
  • Abduljalil M; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, USA.
  • Abdulrahman A; Lagos State Ministry of Health, Lagos, Nigeria.
  • Acosta-Ampudia Y; Internal Medicine, Bahrain Defence Force Hospital, Riffa, Bahrain.
  • Aguilar-Guisado M; Medical Team, National Task Force for Combating the Coronavirus (COVID19), Riffa, Bahrain.
  • Al-Beidh F; Mohammed Bin Khalifa Cardiac Centre, Awali, Bahrain.
  • Alejandria MM; Center for Autoimmune Diseases Research (CREA), Universidad del Rosario, Bogotá, Colombia.
  • Alfonso RN; Infectious Diseases, Microbiology and Preventive Medicine Unit, Hospital Universitario Virgen del Rocío, Seville, Spain.
  • Ali M; Surgery and Cancer, Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, UK.
  • AlQahtani M; Department of Medicine, Division of Infectious Diseases, University of the Philippines-Philippine General Hospital, Manila, Philippines.
  • AlZamrooni A; Department of Medicine, Division of Hematology, University of the Philippines-Philippine General Hospital, Manila, Philippines.
  • Anaya JM; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Ang MAC; Medical Team, National Task Force for Combating the Coronavirus (COVID19), Riffa, Bahrain.
  • Aomar IF; Microbiology, Infectious Diseases, Bahrain Defence Force Hospital, Riffa, Bahrain.
  • Argumanis LE; Microbiology, Royal College of Surgeons in Ireland-Medical University in Bahrain, Riffa, Bahrain.
  • Averyanov A; Internal Medicine, Salmaniya Medical Complex, Manama, Bahrain.
  • Baklaushev VP; Center for Autoimmune Diseases Research (CREA), Universidad del Rosario, Bogotá, Colombia.
  • Balionis O; Department of Laboratories, Division of Blood Bank, University of the Philippines-Philippine General Hospital, Manila, Philippines.
  • Benfield T; Department of Internal Medicine, Hospital Universitario San Cecilio, Granada, Spain.
  • Berry S; Banco de Sangre, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
  • Birocco N; Pulmonary Division, Federal Scientific and Clinical Center of Specialized Medical Care and Medical Technologies of the Federal Medical and Biological Agency, Moscow, Russian Federation.
  • Bonifacio LB; Fundamental Medicine Department, Pulmonology Scientific and Research Institute under Federal Medical and Biological Agency, Moscow, Russian Federation.
  • Bowen AC; Fundamental Medicine Department, Pulmonology Scientific and Research Institute under Federal Medical and Biological Agency, Moscow, Russian Federation.
  • Bown A; Cell Culture Laboratory, Biomedical Research, Federal Scientific and Clinical Center of Specialized Medical Care and Medical Technologies of the Federal Medical and Biological Agency, Moscow, Russian Federation.
  • Cabello-Gutierrez C; Pulmonary Division, Federal Scientific and Clinical Center of Specialized Medical Care and Medical Technologies of the Federal Medical and Biological Agency, Moscow, Russian Federation.
  • Camacho B; Laboratory of Personalized Medicine, Pulmonology Scientific and Research Institute under Federal Medical and Biological Agency, Moscow, Russian Federation.
  • Camacho-Ortiz A; Center for Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
  • Campbell-Lee S; Berry Consultants, Austin, USA.
  • Cao DH; Department of Oncology, University Hospital Città della Salute e della Scienza di Torino, Turin, Italy.
  • Cardesa A; Department of Medicine, Division of Hematology, University of the Philippines-Philippine General Hospital, Manila, Philippines.
  • Carnate JM; Menzies School of Health Research, Casuarina, Australia.
  • Castillo GJJ; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Australia.
  • Cavallo R; Department of Infectious Diseases, Perth Children's Hospital, Nedlands, Australia.
  • Chowdhury FR; Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, UK.
  • Chowdhury FUH; Department Research in Virology and Mycology, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.
  • Ciccone G; Instituto Distrital de Ciencia Biotecnología e Investigación en Salud (IDCBIS), Bogotá, Colombia.
  • Cingolani A; Department of Infectious Diseases, Universidad Autónoma de Nuevo León, Monterrey, Mexico.
  • Climacosa FMM; Pathology, University of Illinois at Chicago, Chicago, USA.
  • Compernolle V; Department of Medicine, Division of Nephrology, Henry Ford Hospital, Detroit, USA.
  • Cortez CFN; Clinical Department, Red Andaluza de Diseño y Traslacion de Terapias Avanzadas, Sevilla, Spain.
  • Costa Neto A; Department of Laboratories, University of the Philippines-Philippine General Hospital, Manila, Philippines.
  • D'Antico S; Department of Medicine, Division of Hematology, University of the Philippines-Philippine General Hospital, Manila, Philippines.
  • Daly J; Department of Laboratory Medicine, Unit of Microbiology and Virology, University Hospital Città della Salute e della Scienza di Torino, Turin, Italy.
  • Danielle F; Internal Medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
BMC Infect Dis ; 21(1): 1170, 2021 Nov 20.
Article in English | MEDLINE | ID: covidwho-1526605
ABSTRACT

BACKGROUND:

Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https//doi.org/10.17605/OSF.IO/GEHFX ).

METHODS:

In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence.

RESULTS:

A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis.

CONCLUSIONS:

Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Controlled clinical trial / Randomized controlled trials / Reviews / Risk factors / Systematic review Limits: Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06829-7

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Controlled clinical trial / Randomized controlled trials / Reviews / Risk factors / Systematic review Limits: Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06829-7