Tomoko Suzuki, Natsumi Saito, Tetsuhiro Yoshino, Sadahiro Sempuku, Rie Katori, Takuhiro Yamaguchi, Masayuki Kashima, Akihiko Kashio, Mahiko Nagase, Eiichi Tahara, Mosaburo Kainuma, Kotaro Nochioka, Susumu Fujii, Norio Suda, Seiichi Kobayashi, Satoko Minakawa, Tadamichi Mitsuma, Yutaka Tanaka, Masaru Mimura, Tadashi Ishii, Shih-Wei Chiu, Hajime Nakae, Toshiaki Saito, Yasuhito Irie, Mayuko Yamazaki, Shigeki Chiba, Shuichi Abe, Ryutaro Arita, Takashi Ito, Hirofumi Maehara, Shin Takayama, Fumihiro Saitoh, Kayo Nakamoto, Rie Ono, Tatsuya Ishige, Takao Namiki, Sayaka Koizumi, Tatsuya Nogami, Akiko Kikuchi, Kenichi Yokota, Hiroki Kai, Koichiro Tanaka, Yoshinobu Nakada, Hiroko Sato, Osamu Shimooki, Tomoaki Ishigami, and Takuya Masuda
Aim: We present the study protocol of a multicenter, retrospective observational study that aims to investigate the efficacy of the actual treatment (the efficacy of conventional and Kampo medicines) of patients with mild to moderate or suspected coronavirus disease (COVID-19) Methods: This study is designed as a multicenter, retrospective observational study Outpatients and inpatients will be recruited from Japanese hospitals The inclusion criteria are as follows: having or suspected to have COVID-19, mild to moderate COVID-19, symptomatic, ≥20 years of age, male or female, able to communicate in Japanese, and treated with conventional and Kampo medicine The exclusion criteria are: unable to provide informed consent due to dementia, psychosis, or psychiatric symptoms, severe COVID-19, or determined unsuitable for this study The sample size is set at 1000, as this number of people can be treated at the collaborating medical institutions during the study period Results: The main outcome is the number of days without fever, with a body temperature of less than 37°C The secondary outcome is set at common cold-like symptoms other than fever (fatigue, cough, shortness of breath, sputum, diarrhea) and severity of illness and hospitalization up to 14 days after the visit Trial registration: The trial was registered in the University Hospital Medical Information Network (Reservation No UMIN000041301) on August 4, 2020 Conclusion: Our study will explore the contribution of conventional and Kampo medicine in the treatment of patients with mild and moderate COVID-19