Jieji Xuanfei Chuyi granules in the treatment of COVID-19: A randomized, open-label, parallel-controlled clinical trial

Background:New drugs are needed for coronavirus disease 2019 (COVID-19). Methods:We conducted a randomized, open-label, positive-drug parallel-controlled trial to evaluate Jieji Xuanfei Chuyi granules (JJXFCY), a Chinese patent medicine, administered within 7 days of the onset of symptoms of mild-to-moderate, laboratory-confirmed COVID-19 in adults. Participants (n = 120) received JJXFCY or Lianhua Qingwen granules (LHQW), as control, 3 times daily. The primary outcome was the time for negative reverse transcription-PCR severe acute respiratory syndrome coronavirus 2 test and symptom relief after 7 days of treatment. The primary safety end point was adverse events. Results:Baseline characteristics were mostly similar in the JJXFCY and LHQW groups. After 7 days of treatment, clinical symptoms were relieved in both groups to a certain extent. Fever, nausea, vomiting, and sticky stool disappeared on day 7. After 15 days, cough, sputum, and nasal congestion were mainly observed. After 28 days, cough, shortness of breath, phlegm, and runny nose still existed in some subjects. No deaths were observed. Adverse events occurred in 21.7% (13/60) and 15% (9/60) of JJXFCY and LHQW groups, respectively. Conclusion:JJXFCY has therapeutic effects in treating mild COVID-19 cases. It reduced the persistence of COVID-19 symptoms, improved outcomes, and reduced the risk of hospitalization or death in adults with COVID-19.