Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Mean clinical recovery time (hours)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at time of signing Informed Consent Form.
- •Laboratory (RT-PCR) confirmed infection with CoVID-
- •Hospitalised with Fever(≥36.7℃ -axilla or oral temperature ≥ 38.0 ℃ or ≥38.6°C tympanic or rectal) and cough;
- •No difficulty swallowing oral medications.
- •Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
排除标准
- •Allergies, known to be allergic to research drugs or drug excipients;
- •Patient weight is less than 40 kg;
- •Respiratory distress-RR≥30 / min on room air,or SPO2≤ 93%, or PaO2/FiO2 ≤300mmHg (1mmHg = 0.133kPa)
- •The clinician judges that ICU monitoring treatment is needed;
- •Patients who have participated in other clinical trials within 1 month;
- •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));
- •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;
- •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.
研究组 & 干预措施
Yin Hu Qing Wen Decoction Group
Based on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days.
干预措施: YinHu QingWen Decoction (Drug)
Yin Hu Qing Wen Decoction Group
Based on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days.
干预措施: standard western medicine treatment (Other)
Yinhu Qingwen Decoction low-dose group
Based on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days.
干预措施: YinHu QingWen Decoction(low dose) (Drug)
Yinhu Qingwen Decoction low-dose group
Based on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days.
干预措施: standard western medicine treatment (Other)
Integrated Chinese and Western Medicine group
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.
干预措施: Chinese medicine treatment (Other)
Integrated Chinese and Western Medicine group
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.
干预措施: standard western medicine treatment (Other)
结局指标
主要结局
Mean clinical recovery time (hours)
时间窗: up to 28 days
The clinical recovery time is defined as the time from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria: (1) Fever: ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic;(2)Respiratory rate - ≤24/minute on room air; 3) Oxygen saturation - \>94% on room air; (4) Cough - mild or absent on a patient reported scale (cough symptoms score ≤ 2 points).
次要结局
- Severe case incidence(up to 28 days)
- Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve.(up to 28 days)
- Frequency of respiratory progression(up to 28 days)
- Frequency of serious adverse events(up to 28 days)
- Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen(up to 28 days)
- Time to defervescence (in those with fever at enrolment)(up to 28 days)
- Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)(up to 28 days)
- 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)(up to 28 days)
- Frequency of requirement for supplemental oxygen or non-invasive ventilation(up to 28 days)
- Proportion of re-hospitalization or admission to ICU(up to 28 days)
- All-cause mortality(up to 28 days)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences