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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278963
Recruitment Status : Suspended (There were no eligible patients in the paticipated centers.)
First Posted : February 20, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

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.


Condition or disease Intervention/treatment Phase
CoVID-19 Chinese Medicine Drug: YinHu QingWen Decoction Drug: YinHu QingWen Decoction(low dose) Other: Chinese medicine treatment Other: standard western medicine treatment Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: 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.
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.

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.

Placebo Comparator: 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.
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: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Mean clinical recovery time (hours) [ Time Frame: 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).



Secondary Outcome Measures :
  1. Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen [ Time Frame: up to 28 days ]
  2. Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
  3. Time to defervescence (in those with fever at enrolment) [ Time Frame: up to 28 days ]
  4. Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) [ Time Frame: up to 28 days ]
  5. 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) [ Time Frame: up to 28 days ]
  6. Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
  7. Frequency of respiratory progression [ Time Frame: up to 28 days ]
    Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.

  8. Severe case incidence [ Time Frame: up to 28 days ]
    Severe case is defined as respiratory rate ≥30/minute on room air;or Oxygen saturation - ≤94% on room air;or PaO2/FiO2≤300mmHg.

  9. Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
  10. All-cause mortality [ Time Frame: up to 28 days ]
  11. Frequency of serious adverse events [ Time Frame: up to 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278963


Locations
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China, Hubei
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, China, 434000
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
Wuhan, Hubei, China, 430200
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China, 441000
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Wei Zhang Jingzhou Hospital of Traditional Chinese Medicine
Principal Investigator: Jiang-Rong Huang, M.D. Yangtze University Health Science Center
Principal Investigator: Xiao-Dong Li, M.D. Hubei Hospital of Traditional Chinese Medicine
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Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04278963    
Other Study ID Numbers: YHQW-V3.0
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No