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Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19: A Meta-analysis.
Troxel, Andrea B; Petkova, Eva; Goldfeld, Keith; Liu, Mengling; Tarpey, Thaddeus; Wu, Yinxiang; Wu, Danni; Agarwal, Anup; Avendaño-Solá, Cristina; Bainbridge, Emma; Bar, Katherine J; Devos, Timothy; Duarte, Rafael F; Gharbharan, Arvind; Hsue, Priscilla Y; Kumar, Gunjan; Luetkemeyer, Annie F; Meyfroidt, Geert; Nicola, André M; Mukherjee, Aparna; Ortigoza, Mila B; Pirofski, Liise-Anne; Rijnders, Bart J A; Rokx, Casper; Sancho-Lopez, Arantxa; Shaw, Pamela; Tebas, Pablo; Yoon, Hyun-Ah; Grudzen, Corita; Hochman, Judith; Antman, Elliott M.
  • Troxel AB; Department of Population Health, NYU Grossman School of Medicine, New York, New York.
  • Petkova E; Department of Population Health, NYU Grossman School of Medicine, New York, New York.
  • Goldfeld K; Department of Child and Adolescent Psychiatry, NYU Grossman School of Medicine, New York, New York.
  • Liu M; The Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York.
  • Tarpey T; Department of Population Health, NYU Grossman School of Medicine, New York, New York.
  • Wu Y; Department of Population Health, NYU Grossman School of Medicine, New York, New York.
  • Wu D; Department of Environmental Health, NYU Grossman School of Medicine, New York, New York.
  • Agarwal A; Department of Population Health, NYU Grossman School of Medicine, New York, New York.
  • Avendaño-Solá C; Department of Biostatistics, University of Washington School of Public Health, Seattle.
  • Bainbridge E; Department of Population Health, NYU Grossman School of Medicine, New York, New York.
  • Bar KJ; Indian Council of Medical Research, New Delhi, Delhi, India.
  • Devos T; Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
  • Duarte RF; Zuckerberg San Francisco General, University of California San Francisco, San Francisco.
  • Gharbharan A; Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.
  • Hsue PY; Department of Hematology, University Hospitals Leuven and Department of Microbiology and Immunology, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Leuven, Belgium.
  • Kumar G; Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
  • Luetkemeyer AF; Section of Infectious Diseases, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.
  • Meyfroidt G; Zuckerberg San Francisco General, University of California San Francisco, San Francisco.
  • Nicola AM; Indian Council of Medical Research, New Delhi, Delhi, India.
  • Mukherjee A; Zuckerberg San Francisco General, University of California San Francisco, San Francisco.
  • Ortigoza MB; Department of Intensive Care Medicine, University Hospitals Leuven, Leuven, Belgium.
  • Pirofski LA; Hospital Universitário de Brasília, University of Brasília, Brasília, Brazil.
  • Rijnders BJA; Indian Council of Medical Research, New Delhi, Delhi, India.
  • Rokx C; Department of Medicine, NYU Grossman School of Medicine, New York, New York.
  • Sancho-Lopez A; Department of Microbiology, NYU Grossman School of Medicine, New York, New York.
  • Shaw P; Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.
  • Tebas P; Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York.
  • Yoon HA; Section of Infectious Diseases, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.
  • Grudzen C; Section of Infectious Diseases, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.
  • Hochman J; Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
  • Antman EM; Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle.
JAMA Netw Open ; 5(1): e2147331, 2022 01 04.
Article in English | MEDLINE | ID: covidwho-1648384
ABSTRACT
Importance COVID-19 convalescent plasma (CCP) is a potentially beneficial treatment for COVID-19 that requires rigorous testing.

Objective:

To compile individual patient data from randomized clinical trials of CCP and to monitor the data until completion or until accumulated evidence enables reliable conclusions regarding the clinical outcomes associated with CCP. Data Sources From May to August 2020, a systematic search was performed for trials of CCP in the literature, clinical trial registry sites, and medRxiv. Domain experts at local, national, and international organizations were consulted regularly. Study Selection Eligible trials enrolled hospitalized patients with confirmed COVID-19, not receiving mechanical ventilation, and randomized them to CCP or control. The administered CCP was required to have measurable antibodies assessed locally. Data Extraction and

Synthesis:

A minimal data set was submitted regularly via a secure portal, analyzed using a prespecified bayesian statistical plan, and reviewed frequently by a collective data and safety monitoring board. Main Outcomes and

Measures:

Prespecified coprimary end points-the World Health Organization (WHO) 11-point ordinal scale analyzed using a proportional odds model and a binary indicator of WHO score of 7 or higher capturing the most severe outcomes including mechanical ventilation through death and analyzed using a logistic model-were assessed clinically at 14 days after randomization.

Results:

Eight international trials collectively enrolled 2369 participants (1138 randomized to control and 1231 randomized to CCP). A total of 2341 participants (median [IQR] age, 60 [50-72] years; 845 women [35.7%]) had primary outcome data as of April 2021. The median (IQR) of the ordinal WHO scale was 3 (3-6); the cumulative OR was 0.94 (95% credible interval [CrI], 0.74-1.19; posterior probability of OR <1 of 71%). A total of 352 patients (15%) had WHO score greater than or equal to 7; the OR was 0.94 (95% CrI, 0.69-1.30; posterior probability of OR <1 of 65%). Adjusted for baseline covariates, the ORs for mortality were 0.88 at day 14 (95% CrI, 0.61-1.26; posterior probability of OR <1 of 77%) and 0.85 at day 28 (95% CrI, 0.62-1.18; posterior probability of OR <1 of 84%). Heterogeneity of treatment effect sizes was observed across an array of baseline characteristics. Conclusions and Relevance This meta-analysis found no association of CCP with better clinical outcomes for the typical patient. These findings suggest that real-time individual patient data pooling and meta-analysis during a pandemic are feasible, offering a model for future research and providing a rich data resource.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Plasma / Patient Selection / Pandemics / COVID-19 / Hospitalization Type of study: Experimental Studies / Prognostic study / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Plasma / Patient Selection / Pandemics / COVID-19 / Hospitalization Type of study: Experimental Studies / Prognostic study / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article