Accepted for Publication: October 1, 2021.
Published Online: December 13, 2021. doi:10.1001/jamainternmed.2021.6850
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Ortigoza MB et al. JAMA Internal Medicine.
Corresponding Author: Liise-anne Pirofski, MD, Division of Infectious Disease, Department of Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Room 610, Belfer Building, Bronx, NY 10461 (l.pirofski@einsteinmed.org).
The CONTAIN COVID-19 Consortium Authors: Lalitha Parameswaran, MD, MPH; Anthony T. Corcoran, MD; Abhinav Rohatgi, MD; Marta W. Wronska, MO; Xinyuan Wu, MD; Ranjini Srinivasan, MD; Fang-Ming Deng, MD, PhD; Thomas D. Filardo, MD; Jay Pendse, MD, PhD; Simone B. Blaser, MD; Olga Whyte, BSN, RN; Jacqueline M. Gallagher, MSN/BSN, RN; Ololade E. Thomas, MPH, BSN, RN; Danibel Ramos, BSN, RN; Caroline L. Sturm-Reganato, BA, BSN, RN; Charlotte C. Fong, BS, RN; Ivy M. Daus, BSN, RN; Arianne Gisselle Payoen, RN; Joseph T. Chiofolo, DO, MS; Mark T. Friedman, DO; Ding Wen Wu, MD, PhD; Jessica L. Jacobson, MD; Jeffrey G. Schneider, MD; Uzma N. Sarwar, MD; Henry E. Wang, MD; Ryan M. Huebinger, MD; Goutham Dronavalli, MD; Yu Bai, MD; Carolyn Z. Grimes, DrPH; Karen W. Eldin, MD; Virginia E Umana, BS; Jessica G. Martin, MD; Timothy R. Heath, MD; Fatimah O. Bello, MD; Daru Lane Ransford, BA; Maudry Laurent-Rolle, MD, PhD, BS; Sheela V. Shenoi, MD, MPH; Oscar Bate Akide-Ndunge, PhD; Bipin Thapa, MD, MS; Jennifer L. Peterson, PhD; Kelly Knauf; Shivani U. Patel; Laura L. Cheney, MD, PhD; Christopher A. Tormey, MD; Jeanne E. Hendrickson, MD.
Affiliations of The CONTAIN COVID-19 Consortium Authors: Division of Infectious Disease, Department of Medicine, NYU Grossman School of Medicine, New York, New York (Parameswaran, Filardo); Division of Infectious Disease, Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York (Sarwar, Cheney); Department of Medicine, NYU Grossman School of Medicine, New York, New York (X. Wu, Pendse, Blaser, Whyte, Gallagher, Thomas, Ramos, Sturm-Reganato, Fong, Daus, Payoen); Department of Medicine, NYU Long Island School of Medicine, Mineola, New York (Rohatgi, Wronska, Schneider); Division of Infectious Disease, Department of Internal Medicine, The University of Texas Health Science Center at Houston, McGovern Medical School, Houston (Grimes, Umana); Department of Emergency Medicine, The University of Texas Health Science Center at Houston, McGovern Medical School, Houston (Wang, Huebinger); Miami Clinical and Translational Science Institute, University of Miami Miller School of Medicine Miami, Florida (Ransford); Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut (Laurent-Rolle, Shenoi, Akide-Ndunge); Division of Critical Care, Department of Internal Medicine, The University of Texas Health Science Center at Houston, McGovern Medical School, Houston (Dronavalli); Department of Internal Medicine, The University of Texas Rio Grande Valley, Edinburg (Martin, Heath, Bello); Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee (Peterson); Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University, Baltimore, Maryland (Patel); Department of Pathology, NYU Grossman School of Medicine, New York, New York (Deng, D. W. Wu, Jacobson); Clinical and Translational Science Institute of Southern Wisconsin, Medical College of Wisconsin Milwaukee (Knauf); Department of Urology, NYU Long Island School of Medicine, Mineola, New York (Corcoran); Department of Pediatrics, NYU Grossman School of Medicine, New York, New York (Srinivasan); Department of Pathology, NYU Long Island School of Medicine, Mineola, New York (Chiofolo, Friedman); Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Pearl River, New York (Sarwar); Department of Emergency Medicine, The Ohio State University, Ohio (Wang); Department of Pathology and Laboratory Medicine, The University of Texas Health Science Center at Houston, McGovern Medical School, Houston (Bai, Eldin); Department of Medicine, Medical College of Wisconsin, Milwaukee (Thapa); Department of Laboratory Medicine, Yale University School of Medicine, New Haven, Connecticut (Tormey, Hendrickson); Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut (Hendrickson).
Author Contributions: Dr Ortigoza had full access to all data in this study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Ortigoza and Yoon are co-first authors and contributed equally to the study.
Concept and design: Ortigoza, Yoon, Goldfeld, Troxel, Daily, Philley, Desruisseaux, Chandran, Lai, Hilbert, Paroder, Shaker, McPherson, Keller, Grudzen, Hochman, Pirofski.
Acquisition, analysis, or interpretation of data: Ortigoza, Yoon, Goldfeld, Troxel, Daily, Yinxiang Wu, Li, Danni Wu, Cobb, Baptiste, O'Keeffe, Corpuz, Ostrosky-Zeichner, Amin, Zacharioudakis, Jayaweera, Yanyun Wu, Devine, Desruisseaux, Santin, Anjan, Mathew, B. Patel, Nigo, Upadhyay, Kupferman, Dentino, Nanchal, Merlo, Hager, Chandran, Lai, Rivera, Bikash, Lasso, Paroder, Asencio, Liu, Petkova, Bragat, Sacco, Pirofski, Parameswaran, Rohatgi, Wronska, Corcoran, X. Wu, Srinivasan, Deng, Filardo, Pendse, Blaser, Whyte, Gallagher, Thomas, Ramos, Sturm-Reganato, Fong, Daus, Payoen, Chiofolo, Friedman, Jacobson, Schneider, Sarwar, Ransford, Wang, Huebinger, Dronavalli, Bai, Grimes, Eldin, Umana, Martin, Heath, Bello, Laurent-Rolle, Shenoi, Akide Ndunge, Thapa, Peterson, Knauf, S. Patel, Cheney, Tormey, Hendrickson, Ding Wen Wu.
Drafting of the manuscript: Ortigoza, Yoon, Goldfeld, Troxel, Daily, Yinxiang Wu, Li, Liu, Pirofski.
Critical revision of the manuscript for important intellectual content: Ortigoza, Yoon, Goldfeld, Troxel, Daily, Danni Wu, Cobb, Baptiste, O'Keeffe, Corpuz, Ostrosky-Zeichner, Amin, Zacharioudakis, Jayaweera., Yanyun Wu, Philley, Devine, Desruisseaux, Santin, Anjan, Mathew, B. Patel, Nigo, Upadhyay, Kupferman, Dentino, Nanchal, Merlo, Hager, Chandran, Lai, Rivera, Bikash, Lasso, Hilbert, Paroder, Asencio, Petkova, Bragat, Shaker, McPherson, Sacco, Keller, Grudzen, Hochman, Pirofski, Parameswaran, Rohatgi, Wronska, Corcoran, X. Wu, Srinivasan, Deng, Filardo, Pendse, Blaser, Whyte, Gallagher, Thomas, Ramos, Sturm-Reganato, Fong, Daus, Payoen, Chiofolo, Friedman, Jacobson, Schneider, Sarwar, Ransford, Wang, Huebinger, Dronavalli, Bai, Grimes, Eldin, Umana, Martin, Heath, Bello, Laurent-Rolle, Shenoi, Akide Ndunge, Thapa, Peterson, Knauf, S. Patel, Cheney, Tormey, Hendrickson, Ding Wen Wu. Statistical analysis: Goldfeld, Troxel, Yinxiang Wu, Li, Danni Wu, Liu, Petkova.
Obtained funding: Ortigoza, Shaker, McPherson, Sacco, Keller, Grudzen, Hochman, Pirofski.
Administrative, technical, or material support: Daily, Cobb, Baptiste, Zacharioudakis, Yanyun Wu, Philley, Desruisseaux, Santin, Anjan, Mathew, Nigo, Upadhyay, Kupferman, Merlo, Hager, Chandran, Rivera, Bikash, Hilbert, Paroder, Asencio, Bragat, Sacco, Keller, Grudzen, Hochman, Parameswaran, Corcoran, X. Wu, Srinivasan, Deng, Filardo, Blaser, Gallagher, Thomas, Ramos, Daus, Payoen, Chiofolo, Friedman, Schneider, Ransford, Wang, Huebinger, Grimes, Eldin, Umana, Martin, Bello, Laurent-Rolle, Shenoi, Akide Ndunge, Thapa, Peterson, Knauf, Cheney, Tormey, Hendrickson, Ding Wen Wu.
Supervision: Ortigoza, Yoon, Troxel, Daily, O'Keeffe, Corpuz, Ostrosky-Zeichner, Amin, Zacharioudakis, Jayaweera., Philley, Desruisseaux, Anjan, Mathew, B. Patel, Nigo, Kupferman, Nanchal, Chandran, Lai, Hilbert, Paroder, Petkova, Sacco, Keller, Grudzen, Hochman, Pirofski, Parameswaran, Schneider, Ransford, Dronavalli, Grimes, Akide Ndunge.
Conflict of Interest Disclosures: Dr Philley reported receiving personal fees from INSMED as an advisory board member, consultant, researcher, and member of the speaker’s bureau, fees from participating in trials as an investigator from Regeneron, Redhill, AN2, Electromed, and Zambon; fees from the France Foundation speaker's bureau, and fees from the RMEI educational bureau outside the submitted work. Dr Devine reported serving as an investigator for the REGENERON studies. Dr Santin reported receiving grants from Puma, Immunomedics, Gilead, and Synthon; grants and personal fees from Merck; grants from Boehringer-Ingelheim and Genentech, grants and personal fees from Tesaro; and grants and personal fees from Eisai. Dr Chandran reported receiving fees from Biovaxys Technology Corp as a science advisory board member, consulting fees from Axon Advisors Consulting, and fees from Integrum Scientific LLC as a science advisory board member outside the submitted work; in addition, Dr Lai reported receiving consultant fees from Celdara Medical and grants from the Mapp Biopharmaceutical Collaboration and Integrated BioTherapeutics Collaboration outside the submitted work; in addition, Dr Lai had a patent for SARS-CoV2 laboratory diagnostic test pending and a patent for antibodies targeting SARS-CoV2 pending. Dr Shenoi having a spouse who worked for Merck Pharmaceuticals 1997-2007 and retains company stock in his retirement account. No other disclosures were reported.
Funding/Support: CONTAIN COVID-19 was supported in part by philanthropic funds to New York University and Montefiore Medical Center/Albert Einstein College of Medicine, a grant from the G. Harold and Leila Y. Mathers Foundation (Dr Pirofski), a Damon Runyon Cancer Research Foundation Physician-Scientist award (PST-25-19 to Dr Upadhyay), and grants from the NCATS/NIH Centers for Translational Science Awards (CTSA) to New York University (UL1 TR001445), Albert Einstein College of Medicine (UL1 TR002556), Yale University (UL1 TR001863), University of Miami (UL1 TR002736), University of Texas Health Sciences Center Houston (UL1 TR003167), Johns Hopkins University (UL1 TR003098), and Medical College of Wisconsin (UL1TR001436) and by a contract (75A50120C00094) with the Biomedical Advanced Research and Development Authority (BARDA) through the Department of Health and Human Services and the Operation Warp Speed interagency program, which provided support to the New York Blood Center to provide convalescent plasma for the trial. Irma and Abram S. Croll Charitable Trust and the Michael Price Foundation provided support for antibody assays. Montefiore COVID-19 Emergency Fund provided support for clinical expenses.
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The CONTAIN COVID-19 Study Group is listed in Supplement 4.
Data and Safety Monitoring Board: Chair: E. M. Antman, MD; Voting: D. Kuritzkes, MD, S. Brown, MD, MS; Eva Petkova, PhD; A. Bateman-House, PhD; and Mengling Liu, PhD; Non-voting: Ying Lu, MS; Yi Li, MS; Yingzhi Qian, MS; and Yinxiang Wu, MS.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Data Sharing Statement: See Supplement 5.
Additional Contributions: We thank Q2 Solutions for their contributions in performing the viral neutralization assays for this work, in particular, the efforts of Sarah Daijogo, PhD, Rohini Sandesara, PhD, and Robert Bailer, PhD (no additional compensation). We acknowledge all members of the CONTAIN Study Group for their invaluable dedication and contributions to this trial, the hospital nursing professionals and support staff, and the study participants for their courage and willingness to contribute to new scientific knowledge about convalescent plasma. In addition, we acknowledge Sarah Dunsmore, PhD (National Center for Advancing Translational Sciences), for her tireless and outstanding program management, assistance, and invaluable support of the trial. We thank Jeff LaFleur, MA, and his team at the Einstein/Montefiore Biorepository for receiving, handling, and storing plasma samples; the New York Blood Center for supplying CCP for the trial and Donna Strauss, MS, of the New York Blood Center for managing CCP distribution and shipments from the New York Blood Center to trial sites; and Mary Homer, PhD, of the Biomedical Advanced Research Development Authority for providing CCP for the trial via the New York Blood Center.