Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19

Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common 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.

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.

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.