CoVID-19Phase 2/3NCT04278963
Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19
A Phase 2/3 study testing YinHu QingWen Decoction, YinHu QingWen Decoction(low dose) and Chinese medicine treatment in people with CoVID-19 and Chinese Medicine, run by China Academy of Chinese Medical Sciences at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CoVID-19, Chinese Medicine
- What is being tested?
- YinHu QingWen Decoction, YinHu QingWen Decoction(low dose) and Chinese medicine treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2021to May 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at time of signing Informed Consent Form.
- Laboratory (RT-PCR) confirmed infection with CoVID-19.
- 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.
Who cannot join
- 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)
- Shock;
- The clinician judges that ICU monitoring treatment is needed;
- Patients who have participated in other clinical trials within 1 month;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, 434000
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
Wuhan, Hubei, 430200
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, 441000
About this study
Official title: Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19
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.
Read the 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.
- Conditions
- CoVID-19, Chinese Medicine
- Being tested
- YinHu QingWen Decoction, YinHu QingWen Decoction(low dose), Chinese medicine treatment, standard western medicine treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YinHu QingWen DecoctionDrug
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.
YinHu QingWen Decoction(low dose)Drug
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.
Chinese medicine treatmentOther
This intervention will be given with Chinese medicine decoction granula based on the symptoms differentiation of the patients for 10 days.
standard western medicine treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yin Hu Qing Wen Decoction Group | Experimental | Based on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days. Receives: Drug: YinHu QingWen Decoction; Other: standard western medicine treatment |
| Yinhu Qingwen Decoction low-dose group | Placebo comparator | Based on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days. Receives: Drug: YinHu QingWen Decoction(low dose); Other: standard western medicine treatment |
| Integrated Chinese and Western Medicine group | Active comparator | 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. Receives: Other: Chinese medicine treatment; Other: standard western medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean clinical recovery time (hours)
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).
Measured: up to 28 days
Secondary outcomes (11)
Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen
Measured: up to 28 days
Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve.
Measured: up to 28 days
Time to defervescence (in those with fever at enrolment)
Measured: up to 28 days
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)
Measured: 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)
Measured: up to 28 days
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Measured: up to 28 days
Frequency of respiratory progression
Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Measured: up to 28 days
Severe case incidence
Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Measured: up to 28 days
Proportion of re-hospitalization or admission to ICU
Measured: up to 28 days
All-cause mortality
Measured: up to 28 days
Frequency of serious adverse events
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startOct 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: There were no eligible patients in the paticipated centers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Wei Zhang, Principal investigator, Jingzhou Hospital of Traditional Chinese MedicineJiang-Rong Huang, M.D., Principal investigator, Yangtze University Health Science CenterXiao-Dong Li, M.D., Principal investigator, Hubei Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278963
- Sponsor's protocol ID
- YHQW-V3.0
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19
- ClinicalTrials.gov ID
- NCT04278963
- Acronym / sponsor ID
- YHQW-V3.0
- Conditions
- CoVID-19, Chinese Medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There were no eligible patients in the paticipated centers.
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yin Hu Qing Wen Decoction Group | Experimental | Drug: YinHu QingWen Decoction, Other: standard western medicine treatmentBased on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days. |
| Yinhu Qingwen Decoction low-dose group | Placebo comparator | Drug: YinHu QingWen Decoction(low dose), Other: standard western medicine treatmentBased on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days. |
| Integrated Chinese and Western Medicine group | Active comparator | Other: Chinese medicine treatment, Other: standard western medicine treatmentBased 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years at time of signing Informed Consent Form.
- Laboratory (RT-PCR) confirmed infection with CoVID-19.
- 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.
Key exclusion criteria (9 listed)
- 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)
- Shock;
- The clinician judges that ICU monitoring treatment is needed;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YinHu QingWen DecoctionYinHu 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 | Yin Hu Qing Wen Decoction Group |
| 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. | Drug | Yinhu Qingwen Decoction low-dose group |
| Chinese medicine treatmentThis intervention will be given with Chinese medicine decoction granula based on the symptoms differentiation of the patients for 10 days. | Other | Integrated Chinese and Western Medicine group |
| standard western medicine treatmentStandard western medicine treatment is according to the protocol of treatment of CoVID-19 infection according to guideline appoved by National Health Commission of China. | Other | Integrated Chinese and Western Medicine group, Yin Hu Qing Wen Decoction Group, Yinhu Qingwen Decoction low-dose group |
Primary outcome
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).
11 secondary outcomes
Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen
Time frame: up to 28 days
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
Time to defervescence (in those with fever at enrolment)
Time frame: up to 28 days
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)
Time frame: 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)
Time frame: up to 28 days
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time frame: up to 28 days
Frequency of respiratory progression
Time frame: up to 28 days
Severe case incidence
Time frame: up to 28 days
Proportion of re-hospitalization or admission to ICU
Time frame: up to 28 days
All-cause mortality
Time frame: up to 28 days
Frequency of serious adverse events
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang principal investigator
Jingzhou Hospital of Traditional Chinese Medicine
Jiang-Rong Huang, M.D. principal investigator
Yangtze University Health Science Center
Xiao-Dong Li, M.D. principal investigator
Hubei Hospital of Traditional Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing YinHu QingWen Decoction, YinHu QingWen Decoction(low dose) and Chinese medicine treatment in people with CoVID-19 and Chinese Medicine, run by China Academy of Chinese Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean clinical recovery time (hours) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.