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Sullivan DJ, Gebo KA, Shoham S, et al. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv. 2021;doi: 10.1101/2021.12.10.21267485.
Sullivan, D. J., Gebo, K. A., Shoham, S., Bloch, E. M., Lau, B., Shenoy, A. G., Mosnaim, G. S., Gniadek, T. J., Fukuta, Y., Patel, B., Heath, S. L., Levine, A. C., Meisenberg, B. R., Spivak, E. S., Anjan, S., Huaman, M. A., Blair, J. E., Currier, J. S., Paxton, J. H., Gerber, J. M., Petrini, J. R., Broderick, P. B., Rausch, W., Cordisco, M. E., Hammel, J., Greenblatt, B., Cluzet, V. C., Cruser, D., Oei, K., Abinante, M., Hammitt, L. L., Sutcliffe, C. G., Forthal, D. N., Zand, M. S., Cachay, E. R., Raval, J. S., Kassaye, S. G., Foster, E. C., Roth, M., Marshall, C. E., Yarava, A., Lane, K., McBee, N. A., Gawad, A. L., Karlen, N., Singh, A., Ford, D. E., Jabs, D. A., Appel, L. J., Shade, D. M., Ehrhardt, S., Baksh, S. N., Laeyendecker, O., Pekosz, A., Klein, S. L., Casadevall, A., Tobian, A. A. R., & Hanley, D. F. (2021). Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv : the preprint server for health sciences, . https://doi.org/10.1101/2021.12.10.21267485
Sullivan, David J, et al. "Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma." medRxiv : the preprint server for health sciences vol. (2021). doi: https://doi.org/10.1101/2021.12.10.21267485
Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv. 2021 Dec 21; doi: 10.1101/2021.12.10.21267485. PMID: 34981068; PMCID: PMC8722611.
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medRxiv. 2021 Dec 21; doi: 10.1101/2021.12.10.21267485.

Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma.

medRxiv : the preprint server for health sciences

David J Sullivan, Kelly A Gebo, Shmuel Shoham, Evan M Bloch, Bryan Lau, Aarthi G Shenoy, Giselle S Mosnaim, Thomas J Gniadek, Yuriko Fukuta, Bela Patel, Sonya L Heath, Adam C Levine, Barry R Meisenberg, Emily S Spivak, Shweta Anjan, Moises A Huaman, Janis E Blair, Judith S Currier, James H Paxton, Jonathan M Gerber, Joann R Petrini, Patrick B Broderick, William Rausch, Marie Elena Cordisco, Jean Hammel, Benjamin Greenblatt, Valerie C Cluzet, Daniel Cruser, Kevin Oei, Matthew Abinante, Laura L Hammitt, Catherine G Sutcliffe, Donald N Forthal, Martin S Zand, Edward R Cachay, Jay S Raval, Seble G Kassaye, E Colin Foster, Michael Roth, Christi E Marshall, Anusha Yarava, Karen Lane, Nichol A McBee, Amy L Gawad, Nicky Karlen, Atika Singh, Daniel E Ford, Douglas A Jabs, Lawrence J Appel, David M Shade, Stephan Ehrhardt, Sheriza N Baksh, Oliver Laeyendecker, Andrew Pekosz, Sabra L Klein, Arturo Casadevall, Aaron A R Tobian, Daniel F Hanley

PMID: 34981068 PMCID: PMC8722611 DOI: 10.1101/2021.12.10.21267485

Abstract

BACKGROUND: The efficacy of polyclonal high titer convalescent plasma to prevent serious complications of COVID-19 in outpatients with recent onset of illness is uncertain.

METHODS: This multicenter, double-blind randomized controlled trial compared the efficacy and safety of SARS-CoV-2 high titer convalescent plasma to placebo control plasma in symptomatic adults ≥18 years positive for SARS-CoV-2 regardless of risk factors for disease progression or vaccine status. Participants with symptom onset within 8 days were enrolled, then transfused within the subsequent day. The measured primary outcome was COVID-19-related hospitalization within 28 days of plasma transfusion. The enrollment period was June 3, 2020 to October 1, 2021.

RESULTS: A total of 1225 participants were randomized and 1181 transfused. In the pre-specified modified intention-to-treat analysis that excluded those not transfused, the primary endpoint occurred in 37 of 589 (6.3%) who received placebo control plasma and in 17 of 592 (2.9%) participants who received convalescent plasma (relative risk, 0.46; one-sided 95% upper bound confidence interval 0.733; P=0.004) corresponding to a 54% risk reduction. Examination with a model adjusting for covariates related to the outcome did not change the conclusions.

CONCLUSION: Early administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic.

TRIAL REGISTRATION: ClinicalTrials.gov number, NCT04373460 .

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