Unraveling COVID-19: A Large-Scale Characterization of 4.5 Million COVID-19 Cases Using CHARYBDIS.

Routinely collected real world data (RWD) have great utility in aiding the novel coronavirus disease (COVID-19) pandemic response. Here we present the international Observational Health Data Sciences and Informatics (OHDSI) Characterizing Health Associated Risks and Your Baseline Disease In SARS-COV-2 (CHARYBDIS) framework for standardisation and analysis of COVID-19 RWD. We conducted a descriptive retrospective database study using a federated network of data partners in the United States, Europe (the Netherlands, Spain, the UK, Germany, France and Italy) and Asia (South Korea and China). The study protocol and analytical package were released on 11th June 2020 and are iteratively updated via GitHub. We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical We aggregated over 22,000 unique characteristics describing patients with COVID-19. All comorbidities, symptoms, medications, and outcomes are described by cohort in aggregate counts and are readily available online. Globally, we observed similarities in the USA and Europe: more women diagnosed than men but more men hospitalized than women, most diagnosed cases between 25 and 60 years of age versus most hospitalized cases between 60 and 80 years of age. South Korea differed with more women than men hospitalized. Common comorbidities included type 2 diabetes, hypertension, chronic kidney disease and heart disease. Common presenting symptoms were dyspnea, cough and fever. Symptom data availability was more common in hospitalized cohorts than diagnosed. We constructed a global, multi-centre view to describe trends in COVID-19 progression, management and evolution over time. By characterising baseline variability in patients and geography, our work provides critical context that may otherwise be misconstrued as data quality issues. This is important as we perform studies on adverse events of special interest in COVID-19 vaccine surveillance.

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© 2022 Kostka et al.

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Ms. Kostka was an employee of IQVIA during the conduct of this study and received grant funding from the NIH NCATS National COVID Cohort Collaborative and the Bill and Melinda Gates Foundation. Mr. Sena is an employee and holds stock at Janssen Research & Development, a Johnson and Johnson family of companies. Dr. Golozar reports personal fees from Regeneron Pharmaceuticals, outside the submitted work. She is a full-time employee at Regeneron Pharmaceuticals. This work was not conducted at Regeneron Pharmaceuticals. Dr. Nyberg was an employee of AstraZeneca until 2019 and hold some shares. Dr. Wilcox reports grants from Bill and Melinda Gates Foundation, grants from National Institute of Health, during the conduct of the study. Mr. Andryc is an employee of Janssen Research & Development, a subsidiary of Johnson & Johnson. Dr. Reich is an employee of IQVIA. Dr. Blacketer reports she is an employee and holds stock at Janssen Research & Development, a Johnson and Johnson family of companies. Dr. Morales is supported by a Wellcome Trust Clinical Research Development Fellowship (Grant 214588/Z/18/Z) and reports grants from Chief Scientist Office (CSO), grants from Health Data Research UK (HDR-UK), grants from National Institute of Health Research (NIHR), outside the submitted work. Mr. DeFalco reports he is an employee and holds stock at Janssen Research & Development, a Johnson and Johnson family of companies. Mr. Thomas reports grants from Bill and Melinda Gates Foundation (INV-016910), grants from National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002369 to his institution, during the conduct of the study. Dr Jiang Bian reports grants from NIH/NIEHS (R21ES032762), during the conduct of the study. Dr. Posada reports grants from National Library of Medicine, during the conduct of the study. Dr. Natarajan reports grants from US NIH, during the conduct of the study. Dr. Matheny reports grants from US NIH, grants from US VA HSR&D, during the conduct of the study. Dr. Weiskopf reports personal fees from Merck, during the conduct of the study and outside the submitted work. Dr. Shah reports grants from National Library of Medicine, during the conduct of the study. Dr. Park reports grants from Ministry of Trade, Industry & Energy, Republic of Korea, grants from Ministry of Health & Welfare, Republic of Korea, grants from Bill & Melinda Gates Foundation, during the conduct of the study. Mr Robert Schuff reports grants from Gates Foundation, grants from NIH-NCATS, during the conduct of the study. Ms. Seager is an employee of IQVIA. Dr. DuVall reports grants from Anolinx, LLC, Astellas Pharma, Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim International GmbH, Celgene Corporation, Eli Lilly and Company, Genentech Inc., Genomic Health, Inc., Gilead Sciences Inc., GlaxoSmithKline PLC, Innocrin Pharmaceuticals Inc., Janssen Pharmaceuticals, Inc., Kantar Health, Myriad Genetic Laboratories, Inc., Novartis International AG, and Parexel International Corporation through the University of Utah or Western Institute for Veteran Research outside the submitted work. Dr. Fortin is an employee of Janssen R&D, a subsidiary of Johnson and Johnson. Dr. Subbian reports grants from State of Arizona; Arizona Board of Regents, during the conduct of the study; grants from National Science Foundation (grant# 1838745), grants from Agency for Healthcare Research and Quality, grants from National Institutes of Health, outside the submitted work. Dr. Rijnbeek reports grants from Innovative Medicines Initiative, Janssen Research and Development, during the conduct of the study. He also works for a research institute which receives/received unconditional research grants from Yamanouchi, Pfizer-Boehringer Ingelheim, GSK, Amgen, UCB, Novartis, Astra-Zeneca, Chiesi, Janssen Research and Development, none of which relate to the content of this work. Dr. Hripcsak reports grants from US NIH and Janssen Research. Dr. Ryan is an employee of Janssen Research and Development and shareholder of Johnson & Johnson. Dr. Suchard reports grants from US National Institutes of Health, Department of Veterans Affairs, during the conduct of the study; grants and/or personal fees from IQVIA, Janssen Research and Development, US Food and Drug Administration, and Private Health Management, outside the submitted work. Dr. Prieto-Alhambra reports grants, non-financial support, speaker/consultancy services and/or advisory board membership from AMGEN, UCB Biopharma, and Les Laboratoires Servier, outside the submitted work; and Janssen, on behalf of IMI-funded EHDEN and EMIF consortiums, and Synapse Management Partners have supported training programmes organised by DPA’s Department and open for external participants. The views expressed are those of the authors and do not necessarily represent the views or policy of the Department of Veterans Affairs or the United States Government. No other relationships or activities that could appear to have influenced the submitted work. The authors report no other conflicts of interest in this work.