Japanese Multicenter Research of COVID-19 by Assembling Real-world Data: A Study Protocol.

Background: Data on the evaluation of the clinical course of coronavirus disease 2019 (COVID-19) and the efficacy of treatments after hospitalization in Japan are limited.

Objective: This study aimed to construct a database of confirmed COVID-19 cases in Japan and promptly address unresolved research issues.

Methods: This multicenter observational study included patients who had a laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and were discharged from each participating institution between January 1 and September 31, 2020. We called for participating facilities and research proposals until the end of September 2020. The research steering committee members provided advice to co-investigators on refining their research proposals and analyses. After developing the research proposal, we collected clinical information, facility information, and laboratory data from each participating institution. Clinical information was also obtained from the Diagnosis Procedure Combination (DPC) data using a dedicated software called DPC hash application.

Analysis: We planned to conduct an analysis based on the research proposal. Overall, 66 institutions from Japan announced their participation, and 102 research proposals were selected for the analyses. Research areas from the proposals included epidemiology, pathophysiology, therapeutic agents, ventilator settings, cost-benefit analyses, and prognosis prediction for COVID-19.

Contribution And Significance To The Field: We have established an efficient data collection system and clinical research team for COVID-19 infection studies. The results of this study may be utilized in future response strategies for COVID-19.