Clinical trial NCT04278963: Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19
Official title: Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: CoVID-19
Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Mean clinical recovery time (hours)
timeFrame: up to 28 days
Secondary outcomes:
measure: Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen
timeFrame: up to 28 days
measure: Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve.
timeFrame: up to 28 days
measure: Time to defervescence (in those with fever at enrolment)
timeFrame: up to 28 days
measure: Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)
timeFrame: up to 28 days
measure: Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate)
timeFrame: up to 28 days
measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation
timeFrame: up to 28 days
measure: Frequency of respiratory progression
timeFrame: up to 28 days
measure: Severe case incidence
timeFrame: up to 28 days
measure: Proportion of re-hospitalization or admission to ICU
timeFrame: up to 28 days
measure: All-cause mortality
timeFrame: up to 28 days
measure: Frequency of serious adverse events
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Jingzhou
country: China
facility: Jingzhou Hospital of Traditional Chinese Medicine
state: Hubei
city: Wuhan
country: China
facility: Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Hospital of Traditional Chinese Medicine
state: Hubei
Study officials:
affiliation: Jingzhou Hospital of Traditional Chinese Medicine
name: Wei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangtze University Health Science Center
name: Jiang-Rong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Xiao-Dong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: