COVID-19Phase 2/3NCT04310865
Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
A Phase 2/3 study testing Yinhu Qingwen Granula, Yin Hu Qing Wen Granula(low does) and standard medical treatment in people with COVID-19 and Severe Pneumonia, run by Zhong Wang at 4 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, Severe Pneumonia, Chinese Medicine
- What is being tested?
- Yinhu Qingwen Granula, Yin Hu Qing Wen Granula(low does) and standard medical treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 4 sitesChina
- Study dates
- Nov 2021to Apr 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;
- Those who meet the diagnosis of severe new coronavirus pneumonia with laboratory confirmed infection with CoVID-19;
- Lung involvement confirmed with chest imaging;
- Hospitalized with a Pa02/Fi02 ratio ≤300mgHg;
- 40%> lymphocyte percentage ≥5%;
- No difficulty swallowing oral medications.
Who cannot join
- Allergies, those who are known to be allergic to research drugs or drug excipients;
- The patient weighs less than 40 kg;
- Patients with diarrhea;
- Shock;
- Patients with respiratory failure at the time of enrollment who need invasive mechanical ventilation;
- The clinician judges that ICU admission is needed;
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- Patients who 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 the local laboratory reference range): ALT or AST level> 5 times the upper limit of normal range (ULN) or ALT or AST level> 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 after study treatment;
- Will be transferred to another hospital which is not the study site within 72 hours.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital
Wuhan, Hubei, 430071
Wuhan No.7 Hospital/North China University of Science and Technology Affiliated Hospital
Wuhan, Hubei, 430071
Zhongnan Hospital of Wuhan University/Tanshan People's Hospital
Wuhan, Hubei, 430071
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
Wuhan, Hubei, 430200
About this study
Official title: An Adaptive, Randomized, Double-blind, Parallel-controlled Clinical Trial of Yinhu Qingwen Granula for the Treatment of Severe 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 Granula as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this adaptive, randomized,double-blind,controlled trial will evaluate the efficacy and safety of Yinhu Qingwen Granula in patients hospitalized with severe CoVID-19.
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 Granula was a kind of herbal granula made from "Yinhu Qingwen Decoction", which 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 improvement of the changes in the ratio of PaO2 to FiO2 from the baseline for patients with severe CoVID-19 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, Severe Pneumonia, Chinese Medicine
- Being tested
- Yinhu Qingwen Granula, Yin Hu Qing Wen Granula(low does), standard medical treatment
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yinhu Qingwen GranulaDrug
Yinhu Qingwen Granula is a kind of herbal granula made from "Yinhu Qingwen Decoction", which consits of 11 Chinese herbal medicine as Honeysuckle, Polygonum cuspidatum, Schizonepeta, Longspur epimedium, etc. 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.
Yin Hu Qing Wen Granula(low does)Drug
This intervention is given as 10% dose of YinHu QingWen Granula.The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml).
standard medical treatmentOther
Standard medical treatment is adhered to the protocol of the treatment for the severe CoVID-19 according to the guideline approved by National Health Commission of China.
| Study group | Role | What they receive |
|---|---|---|
| Yinhu Qingwen Granula Group | Experimental | Based on the standard medical treatment, the patients will be given Yinhu Qingwen Granula for 10 days. Receives: Drug: Yinhu Qingwen Granula; Other: standard medical treatment |
| Yinhu Qingwen Granula Low-dose Group | Placebo comparator | Based on the standard medical treatment, the patients will be given 10% dose of Yinhu Qingwen Granula for 10 days. Receives: Drug: Yin Hu Qing Wen Granula(low does); Other: standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the ratio of PaO2 to FiO2 from baseline
Measured: Day 10
Secondary outcomes (14)
PaO2
Measured: up to 30 days
blood oxygen saturation (SpO2)
Measured: up to 30 days
clinical status rating on the 7-point ordinal scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measured: up to 30 days
Time to Clinical Improvement (TTCI)
TTCI is defined as the time (in days) from initiation of study treatment (Yinhu Qingwen Granula or its low-dose granula) until a decline of two categories from status at randomisation on the 7-point ordinal scale of clinical status which ranges from 0 (death) to 6 (Not hospitalized, no limitations on activities).
Measured: up to 30 days
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use
Measured: up to 30 days
Duration (hours) of invasive mechanical ventilation use
Measured: up to 30 days
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use
Measured: up to 30 days
Duration (days) of Oxygen use
Measured: up to 30 days
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment
Measured: Day 10
The counts/percentage of Lymphocyte
Measured: up to 30 days
Time to hospital discharge with clinical recovery from the randomisation
Measured: up to 30 days
The incidence of critical status conversion in 30 days
Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
Measured: up to 30 days
All-cause mortality within 30 days
Measured: up to 30 days
Frequency of severe adverse drug events
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study startNov 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: There were no eligible patients with CoVID-19 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Leishenshan Hospital, The First Affiliated Hospital of Dalian Medical University, Tanshan People's Hospital, North China University of Science and Technology, Jizhong Energy Fengfeng Group Hospital
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Dong Shang, M.D., Principal investigator, Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical UniversityJiang-Rong Huang, M.D., Principal investigator, Yangtze University Health Science CenterXiao-Dong Li, M.D., Principal investigator, Hubei Hospital of Traditional Chinese MedicineZhong Wang, M.D., Study director, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310865
- Sponsor's protocol ID
- YHQW-Severe-V2.0
- Status last verified
- Jul 2021
- First submitted
- 15 Mar 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
- An Adaptive, Randomized, Double-blind, Parallel-controlled Clinical Trial of Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
- ClinicalTrials.gov ID
- NCT04310865
- Acronym / sponsor ID
- YHQW-Severe-V2.0
- Conditions
- COVID-19, Severe Pneumonia, Chinese Medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There were no eligible patients with CoVID-19 in the paticipated centers.
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Collaborators
- Wuhan Leishenshan Hospital, The First Affiliated Hospital of Dalian Medical University, Tanshan People's Hospital, North China University of Science and Technology, Jizhong Energy Fengfeng Group Hospital
- Study start
- Nov 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 17 Mar 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 Granula as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this adaptive, randomized,double-blind,controlled trial will evaluate the efficacy and safety of Yinhu Qingwen Granula in patients hospitalized with severe CoVID-19.
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 Granula was a kind of herbal granula made from "Yinhu Qingwen Decoction", which 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 improvement of the changes in the ratio of PaO2 to FiO2 from the baseline for patients with severe CoVID-19 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yinhu Qingwen Granula Group | Experimental | Drug: Yinhu Qingwen Granula, Other: standard medical treatmentBased on the standard medical treatment, the patients will be given Yinhu Qingwen Granula for 10 days. |
| Yinhu Qingwen Granula Low-dose Group | Placebo comparator | Drug: Yin Hu Qing Wen Granula(low does), Other: standard medical treatmentBased on the standard medical treatment, the patients will be given 10% dose of Yinhu Qingwen Granula 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 (6 listed)
- Age ≥18 years at time of signing Informed Consent Form;
- Those who meet the diagnosis of severe new coronavirus pneumonia with laboratory confirmed infection with CoVID-19;
- Lung involvement confirmed with chest imaging;
- Hospitalized with a Pa02/Fi02 ratio ≤300mgHg;
- 40%> lymphocyte percentage ≥5%;
Key exclusion criteria (11 listed)
- Allergies, those who are known to be allergic to research drugs or drug excipients;
- The patient weighs less than 40 kg;
- Patients with diarrhea;
- Shock;
- Patients with respiratory failure at the time of enrollment who need invasive mechanical ventilation;
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 GranulaYinhu Qingwen Granula is a kind of herbal granula made from "Yinhu Qingwen Decoction", which consits of 11 Chinese herbal medicine as Honeysuckle, Polygonum cuspidatum, Schizonepeta, Longspur epimedium, etc. 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 Granula Group |
| Yin Hu Qing Wen Granula(low does)This intervention is given as 10% dose of YinHu QingWen Granula.The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). | Drug | Yinhu Qingwen Granula Low-dose Group |
| standard medical treatmentStandard medical treatment is adhered to the protocol of the treatment for the severe CoVID-19 according to the guideline approved by National Health Commission of China. | Other | Yinhu Qingwen Granula Group, Yinhu Qingwen Granula Low-dose Group |
Primary outcome
changes in the ratio of PaO2 to FiO2 from baseline
Time frame: Day 10
14 secondary outcomes
PaO2
Time frame: up to 30 days
blood oxygen saturation (SpO2)
Time frame: up to 30 days
clinical status rating on the 7-point ordinal scale
Time frame: up to 30 days
Time to Clinical Improvement (TTCI)
Time frame: up to 30 days
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use
Time frame: up to 30 days
Duration (hours) of invasive mechanical ventilation use
Time frame: up to 30 days
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use
Time frame: up to 30 days
Duration (days) of Oxygen use
Time frame: up to 30 days
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment
Time frame: Day 10
The counts/percentage of Lymphocyte
Time frame: up to 30 days
Time to hospital discharge with clinical recovery from the randomisation
Time frame: up to 30 days
The incidence of critical status conversion in 30 days
Time frame: up to 30 days
All-cause mortality within 30 days
Time frame: up to 30 days
Frequency of severe adverse drug events
Time frame: up to 30 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.
Dong Shang, M.D. principal investigator
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
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
4 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 Granula, Yin Hu Qing Wen Granula(low does) and standard medical treatment in people with COVID-19 and Severe Pneumonia, run by Zhong Wang at 4 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 6 inclusion and 11 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 4 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?
changes in the ratio of PaO2 to FiO2 from baseline (time frame: Day 10). 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.