Guideline-Based Chinese Herbal Medicine Treatment Plus Standard Care for Severe Coronavirus Disease 2019 (G-CHAMPS): Evidence From China

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 g/=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