yinhu qingwen granula for the treatment of severe covid-19

Conditions: COVID-19; Severe Pneumonia; 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 granula as a potential antiviral chinese medicine based on vivo antiviral studies in covid-19, this adaptive, randomized,double-blind,controlled trial will evaluate the efficacy and safety of yinhu qingwen granula in patients hospitalized with severe covid-19.

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 granula was a kind of herbal granula made from "yinhu qingwen decoction", which 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 improvement of the changes in the ratio of pao2 to fio2 from the baseline for patients with severe covid-19 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. those who meet the diagnosis of severe new coronavirus pneumonia with laboratory confirmed infection with covid-19; 3. lung involvement confirmed with chest imaging; 4. hospitalized with a pa02/fi02 ratio ≤300mghg; 5. 40%\> lymphocyte percentage ≥5%; 6. no difficulty swallowing oral medications. exclusion criteria: 1. allergies, those who are known to be allergic to research drugs or drug excipients; 2. the patient weighs less than 40 kg; 3. patients with diarrhea; 4. shock; 5. patients with respiratory failure at the time of enrollment who need invasive mechanical ventilation; 6. the clinician judges that icu admission is needed; 7. patients who participated in other clinical trials within 1 month; 8. 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)); 9. during the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on the local laboratory reference range): alt or ast level\> 5 times the upper limit of normal range (uln) or alt or ast level\> 3 times uln and total bilirubin levels\> 2 times uln; 10. 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 after study treatment; 11. will be transferred to another hospital which is not the study site within 72 hours.