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

China Academy of Chinese Medical Sciences

Status and phase: Suspended; Phase 3; Phase 2

Conditions: CoVID-19; Chinese Medicine

Treatments: Other: Chinese medicine treatment; Drug: YinHu QingWen Decoction(low dose); Other: standard western medicine treatment; Drug: YinHu QingWen Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT04278963

YHQW-V3.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Yin Hu Qing Wen Decoction Group

Experimental group

Description:

Based on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days.

Treatment:

Drug: YinHu QingWen Decoction

Other: standard western medicine treatment

Yinhu Qingwen Decoction low-dose group

Placebo Comparator group

Description:

Based on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days.

Treatment:

Drug: YinHu QingWen Decoction(low dose)

Other: standard western medicine treatment

Integrated Chinese and Western Medicine group

Active Comparator group

Description:

Based on the standard western medicine treatment, the patients will be given Chinese medicine decotion granula according to their symptoms. The daily dose of Chinese medicine decoction granula will also be dissolved to 600 ml decoction and divided into 3 times(once with 200ml). The Chinese medicine decoction will be given 200ml per time, three times a day for 10 days.

Treatment:

Other: Chinese medicine treatment

Other: standard western medicine treatment