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.
Drug: YinHu QingWen Decoction
YinHu QingWen Decoction (Granula) consits of 11 Chinese herbal medicine as Honeysuckle, Polygonum cuspidatum, Schizonepeta, Longspur epimedium, etc. The decoction granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). It will be given a 200ml per time, three times a day, for 10 days.
Drug: YinHu QingWen Decoction(low dose)
This intervention is given as 10% dose of YinHu QingWen Decoction (Granula).The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). It will be given a 200ml per time, three times a day, for 10 days.
Other: Chinese medicine treatment
This intervention will be given with Chinese medicine decoction granula based on the symptoms differentiation of the patients for 10 days.
Other: standard western medicine treatment
Standard western medicine treatment is according to the protocol of treatment of CoVID-19 infection according to guideline appoved by National Health Commission of China.
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.
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, China
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
Wuhan, Hubei, China
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China