Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study.

ABSTRACT:

Objective

Since Omicron will likely persist, this trial evaluates the safety and efficacy of Shufeng Jiedu Granule (SFJDG) for mild Omicron infection, aims at finding new therapies especially for home-treated patients.

Methods

This randomized, double-blind, placebo-controlled, multi-center phase III trial involves 844 patients, divided into a treatment group (422) and control group (422). Participants will receive SFJDG or placebo for 7 d (1.2 g/bag, 2 bags, 3 times/d). Hospital evaluations will be done on days 1 and 8, with telephone assessments on days 3 and 5. Follow-up continues on days 10 and 14. Diary cards will track symptom scores and safety data. The primary outcome is the time to sustained clinical recovery from corona virus disease 2019 (COVID-19) symptoms. An int

SUBMITTER: Yang L 

PROVIDER: S-EPMC12301922 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature