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Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection.
Shoham, Shmuel; Bloch, Evan M; Casadevall, Arturo; Hanley, Daniel; Lau, Bryan; Gebo, Kelly; Cachay, Edward; Kassaye, Seble G; Paxton, James H; Gerber, Jonathan; Levine, Adam C; Currier, Judith; Patel, Bela; Allen, Elizabeth S; Anjan, Shweta; Appel, Lawrence; Baksh, Sheriza; Blair, Paul W; Bowen, Anthony; Broderick, Patrick; Caputo, Christopher A; Cluzet, Valerie; Cordisco, Marie Elena; Cruser, Daniel; Ehrhardt, Stephan; Forthal, Donald; Fukuta, Yuriko; Gawad, Amy L; Gniadek, Thomas; Hammel, Jean; Huaman, Moises A; Jabs, Douglas A; Jedlicka, Anne; Karlen, Nicky; Klein, Sabra; Laeyendecker, Oliver; Lane, Karen; McBee, Nichol; Meisenberg, Barry; Merlo, Christian; Mosnaim, Giselle; Park, Han-Sol; Pekosz, Andrew; Petrini, Joann; Rausch, William; Shade, David M; Shapiro, Janna R; Singleton, J Robinson; Sutcliffe, Catherine; Thomas, David L.
Afiliação
  • Shoham S; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Bloch EM; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Casadevall A; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Hanley D; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Lau B; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Gebo K; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Cachay E; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Kassaye SG; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Paxton JH; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Gerber J; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Levine AC; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Currier J; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Patel B; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Allen ES; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Anjan S; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Appel L; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Baksh S; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Blair PW; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Bowen A; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Broderick P; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Caputo CA; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Cluzet V; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Cordisco ME; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Cruser D; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Ehrhardt S; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Forthal D; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Fukuta Y; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Gawad AL; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Gniadek T; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Hammel J; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Huaman MA; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Jabs DA; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Jedlicka A; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Karlen N; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Klein S; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Laeyendecker O; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Lane K; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • McBee N; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Meisenberg B; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Merlo C; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Mosnaim G; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Park HS; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Pekosz A; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Petrini J; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Rausch W; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Shade DM; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Shapiro JR; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Singleton JR; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Sutcliffe C; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
  • Thomas DL; Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Micr
medRxiv ; 2021 Dec 14.
Article em En | MEDLINE | ID: mdl-34931202
ABSTRACT

BACKGROUND:

The efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. We hypothesized that CCP might prevent infection when administered before symptoms or laboratory evidence of infection.

METHODS:

This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1320) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was development of SARS-CoV-2 infection.

RESULTS:

180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for SARS-CoV-2 RT-PCR positivity at screening. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. There were 28 adverse events in CCP and 58 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days; p=0.49) and COVID-19 (26.3 vs. 25.9 days; p=0.35) were similar for both groups.

CONCLUSION:

In this trial, which enrolled persons with recent exposure to a person with confirmed COVID-19, high titer CCP as post-exposure prophylaxis appeared safe, but did not prevent SARS-CoV-2 infection. TRIAL REGISTRATION Clinicaltrial.gov number NCT04323800 .
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: MedRxiv Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: MedRxiv Ano de publicação: 2021 Tipo de documento: Article