ABSTRACT: Background: In January, national guidelines were developed and recommended for use throughout China to fight coronavirus disease 2019 (COVID-19). Chinese herbal medicine (CHM) was also included as part of the treatment plans at various stages of COVID-19. Methods: We conducted a pilot randomized, controlled trial in patients with severe COVID-19 in Wuhan, China. Eligible adult patients were randomly assigned in a 2:1 ratio to receive either CHM plus standard care or standard care alone for 7 days. The primary outcome was the change in the disease severity category of COVID-19 after treatment. Results: Between Jan 31, 2020, and Feb 19, 2020, 42 out of 100 screened patients were included in the trial: 28 in the CHM plus standard care group and 14 in the standard care alone group. Among 42 participants who were randomized (mean [SD] age 60.43 years [12.69 years]), 21 (21/42, 50%) were aged ?65 years, 35 (35/42, 83%) were women, and 42 (42/42, 100%) had data available for the primary outcome. For the primary outcome, one patient from each group died during treatment; the odds of a shift toward death was lower in the CHM plus group than in the standard care alone group (common OR 0.59, 95% CI 0.148-2.352, P = 0.454). Three (two from the CHM plus group and one from the standard care alone group) patients progressed from severe to critical illness. After treatment, mild, moderate, and severe COVID-19 disease accounted for 17.86% (5/28) vs. 14.29% (2/28), 71.43% (20/28) vs. 64.29% (9/28), and 0% (0) vs. 7.14% (1/28) of the patients treated with CHM plus standard care vs. standard care alone. Conclusions: For the first time, the G-CHAMPS trial provided valuable information for the national guideline-based CHM treatment of hospitalized patients with severe COVID-19. The effects of CHM in COVID-19 may be clinically important and warrant further consideration and studies. Clinical Trial Registration: http://www.chictr.org.cn/index.aspx. Uniqueidentifier: ChiCTR2000029418.
