Chinese herbal medicine Shufeng Jiedu Capsule for patients with mild to moderate coronavirus disease 2019 (COVID-19): Protocol for a randomized, blinded, placebo control trial

Introduction: Most current Coronavirus disease (COVID-19) infected cases are now diagnosed as mild to moderate. Symptoms such as sore throat, headache, nasal congestion, cough, etc. lack effective treatment for their relief. The registered Chinese herbal medicine Shufeng Jiedu Capsule (SFJD) has been used to treat different epidemics like influenza A virus subtype H1N, and has been shown to improve symptoms such as fever, sore throat, headache, nasal congestion and cough. It has also been widely used to treat COVID-19 in China. This study aims to verify the efficacy and safety of SFJD in patients with mild and moderate COVID-19 infection. Methods: This study is designed as a randomized, blind, placebo control trial. A total of 220 patients in each group will receive either SFJD or placebo three times a day for five days, in addition to standard medical care. Participants will be assessed at baseline, during the treatment period, during the period of isolation in hospital and after hospital discharge on day 7 and 14. The primary outcome is time to alleviation of all COVID-19 related symptoms, including cough, stuffy nose, sore throat, fever or chills, muscle/joint pain, headache, fatigue, etc. Secondary outcomes are time to alleviation of individual COVID-19 related symptoms, time to SARS-CoV-2 virus reverse transcription polymerase chain reaction (RT-PCR) turning to negativity, changes in inflammatory parameters (leukocyte, lymphocyte, C-reactive protein (CRP), serum procalcitonin (PCT), inflammatory factor (Interleukin-6), CD4/CD8 cells), the amount of lung inflammation as ascertained by chest CT and adverse events. Discussion: The study is expected to provide evidence to explore indications and usage of SFJD for COVID-19. The design and methodology could be relevant to research on Chinese herbal medicine for other infectious diseases. Additionally, the results from the follow-up period will provide information on potential longer term symptom alleviation (14 days post COVID-19). Trial registration: ISRCTN14236594, Registered on 3 May 2022.

Automated summary

This study aims to verify the efficacy and safety of the Chinese herbal medicine Shufeng Jiedu Capsule (SFJD) in patients with mild and moderate COVID-19 infection. The study design is a randomized, blind, placebo control trial, and multiple outcome measures will be assessed including time to symptom alleviation, changes in inflammatory parameters, and lung inflammation.