Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study.
10.1016/j.chmed.2025.04.005
- Author:
Li YANG
1
;
Thomas FRIEDEMANN
2
;
Jun PAN
1
;
Xiangyu LI
1
;
Fuxiang WANG
3
;
Yuanlong LIN
3
;
Qiang ZHU
1
;
Sven SCHRÖDER
2
;
Qingsong LIU
4
;
Hongzhou LU
3
Author Information
1. Anhui Jiren Pharmaceutical Group Traditional Chinese Medicine Research Institute Co., Ltd., Anhui Jiren Pharmaceutical Co., Ltd., Bozhou 236800, China.
2. HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center, Hamburg-Eppendorf, Hamburg 20251, Germany.
3. Shenzhen Key Laboratory of Pathogen and Immunity, Shenzhen Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, Second Hospital Affiliated to Southern University of Science and Technology, Shenzhen 518112, China.
4. Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences, Hefei 230031, China.
- Publication Type:Journal Article
- Keywords:
COVID-19 infection;
Shufeng Jiedu Granule;
clinical recovery;
clinical trial;
mild patients;
phase III study;
symptom relief;
traditional Chinese medicine
- From:
Chinese Herbal Medicines
2025;17(3):601-608
- CountryChina
- Language:English
-
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 interim analysis will occur after 70 % of patients complete follow-up, with Type I error correction (α1 = 0.015) at interim analysis based on O'Brien-Fleming-type cumulative error spending function.
RESULTS:This phase III trial evaluates the efficacy and safety of SFJDG for mild COVID-19, focusing on real-world applicability for home-managed patients. The study's randomized, double-blind, placebo-controlled design ensures methodological rigor, while its comprehensive outcome measures address both symptom recovery and treatment safety. By emphasizing symptom resolution and recovery time, the trial aligns with the clinical priorities for managing mild cases of COVID-19. The findings could offer valuable insights into SFJDG's role in improving patient outcomes and addressing gaps left by existing antiviral therapies, particularly in symptom management.
CONCLUSION:The global risk assessment remains high due to the ongoing virulence of SARS-CoV-2 Omicron sub-lineages. This Phase III study adopts a robust methodology to investigate SFJDG as a treatment for mild COVID-19 as well as it's effectiveness and safety. Furthermore, this study aim to provide sufficient scientific evidence for the market registration of SFJDG especially for home-treated patients. If successful, SFJDG could be a meaningful addition to therapeutic options for mild infections, supporting public health strategies in managing the ongoing impact of SARS-CoV-2.
