yinhu qingwen decoction for the treatment of mild / common covid-19

Conditions: CoVID-19; Chinese Medicine

Summary: in december 2019, wuhan, in hubei province, china, became the center of an outbreak of pneumonia caused by covid-19, and the number of cases of infection with covid-19 identified in wuhan increased markedly over the later part of january 2020, with cases identified in multiple other provinces of china and internationally. given no specific antiviral therapy for covid-19 infection and the availability of yinhu qingwen decoction as a potential antiviral chinese medicine based on vivo antiviral studies in covid-19, this randomized,three-arm controlled, single-blind trial will evaluate the efficacy and safety of yinhu qingwen decoction (granula) in patients hospitalized with mild or common covid-19 respiratory disease.

in december 2019, wuhan, in hubei province, china, became the center of an outbreak of pneumonia caused by covid-19, and the number of cases of infection with covid-19 identified in wuhan increased markedly over the later part of january 2020, with cases identified in multiple other provinces of china and internationally. the clinical spectrum of covid-19 infection appears to be wide,including asymptomatic infection, mild upper respiratory disease, severe viral pneumonia with respiratory failure, and even death.however,there is no specific antiviral therapy for covid-19 infection, which provides a window of opportunity for testing candidate antiviral therapies. previous experiences with sars and mers-cov, highlight the need of the early intervention with chinese medicine, and so as for covid-19 infection. the treatment of chinese medicine for covid-19 infection suggested its benefits to improve of clinical outcomes, reduce the risk of disease progression, accelerate recovery, and reduce intensive supportive care and long-term hospitalization. yinhu qingwen decoction (granula) consists of 11 common non-toxic traditional chinese medicine such as polygonum cuspidatum, honeysuckle, nepeta, ligustrum lucidum. previous vivo antiviral studies showed its activity for the inbition of covid-19. this clinical trial is planned to evaluate the mean clinical recovery time for patients with mild and common covid-19 infection as the primary outcome, and to evaluate the effect of the symptoms relief and virus clearance as well as the clinical safety.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years at time of signing informed consent form. 2. laboratory (rt-pcr) confirmed infection with covid-19. 3. hospitalised with fever(≥36.7℃ -axilla or oral temperature ≥ 38.0 ℃ or ≥38.6°c tympanic or rectal) and cough; 4. no difficulty swallowing oral medications. 5. must agree not to enroll in another study of an investigational agent prior to completion of day 28 of study. exclusion criteria: 1. allergies, known to be allergic to research drugs or drug excipients; 2. patient weight is less than 40 kg; 3. respiratory distress-rr≥30 / min on room air,or spo2≤ 93%, or pao2/fio2 ≤300mmhg (1mmhg = 0.133kpa) 4. shock; 5. the clinician judges that icu monitoring treatment is needed; 6. patients who have participated in other clinical trials within 1 month; 7. known patients with impaired renal function (estimated creatinine clearance \<60 ml / min (male: cr (ml / min) = (140-age) × body weight (kg) / 72 × blood creatinine concentration (mg / dl); female: cr (ml / min) = (140-age) × weight (kg) / 85 × blood creatinine concentration (mg / dl)); 8. during the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-alt or ast level\> 5 times the upper limit of normal range (uln) or-alt or ast \> 3 times uln and total bilirubin levels\> 2 times uln; 9. being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.