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Yinhu Qingwen Granula for the Treatment of Severe CoVID-19

Primary Purpose

COVID-19, Severe Pneumonia, Chinese Medicine

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Yinhu Qingwen Granula
Yin Hu Qing Wen Granula(low does)
standard medical treatment
Sponsored by
Zhong Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years at time of signing Informed Consent Form;
  2. Those who meet the diagnosis of severe new coronavirus pneumonia with laboratory confirmed infection with CoVID-19;
  3. Lung involvement confirmed with chest imaging;
  4. Hospitalized with a Pa02/Fi02 ratio ≤300mgHg;
  5. 40%> lymphocyte percentage ≥5%;
  6. No difficulty swallowing oral medications.

Exclusion Criteria:

  1. Allergies, those who are known to be allergic to research drugs or drug excipients;
  2. The patient weighs less than 40 kg;
  3. Patients with diarrhea;
  4. Shock;
  5. Patients with respiratory failure at the time of enrollment who need invasive mechanical ventilation;
  6. The clinician judges that ICU admission is needed;
  7. Patients who participated in other clinical trials within 1 month;
  8. 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));
  9. 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;
  10. 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;
  11. Will be transferred to another hospital which is not the study site within 72 hours.

Sites / Locations

  • Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital
  • Wuhan No.7 Hospital/North China University of Science and Technology Affiliated Hospital
  • Zhongnan Hospital of Wuhan University/Tanshan People's Hospital
  • Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yinhu Qingwen Granula Group

Yinhu Qingwen Granula Low-dose Group

Arm Description

Based on the standard medical treatment, the patients will be given Yinhu Qingwen Granula for 10 days.

Based on the standard medical treatment, the patients will be given 10% dose of Yinhu Qingwen Granula for 10 days.

Outcomes

Primary Outcome Measures

changes in the ratio of PaO2 to FiO2 from baseline

Secondary Outcome Measures

PaO2
blood oxygen saturation (SpO2)
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.
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).
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use
Duration (hours) of invasive mechanical ventilation use
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use
Duration (days) of Oxygen use
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment
The counts/percentage of Lymphocyte
Time to hospital discharge with clinical recovery from the randomisation
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.
All-cause mortality within 30 days
Frequency of severe adverse drug events

Full Information

First Posted
March 15, 2020
Last Updated
July 4, 2021
Sponsor
Zhong Wang
Collaborators
Wuhan Leishenshan Hospital, The First Affiliated Hospital of Dalian Medical University, Tanshan People's Hospital, North China University of Science and Technology Affiliated Hospital, Jizhong Energy Fengfeng Group Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04310865
Brief Title
Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
Official Title
An Adaptive, Randomized, Double-blind, Parallel-controlled Clinical Trial of Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Suspended
Why Stopped
There were no eligible patients with CoVID-19 in the paticipated centers.
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
Collaborators
Wuhan Leishenshan Hospital, The First Affiliated Hospital of Dalian Medical University, Tanshan People's Hospital, North China University of Science and Technology Affiliated Hospital, Jizhong Energy Fengfeng Group Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Severe Pneumonia, Chinese Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yinhu Qingwen Granula Group
Arm Type
Experimental
Arm Description
Based on the standard medical treatment, the patients will be given Yinhu Qingwen Granula for 10 days.
Arm Title
Yinhu Qingwen Granula Low-dose Group
Arm Type
Placebo Comparator
Arm Description
Based on the standard medical treatment, the patients will be given 10% dose of Yinhu Qingwen Granula for 10 days.
Intervention Type
Drug
Intervention Name(s)
Yinhu Qingwen Granula
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Yin Hu Qing Wen Granula(low does)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
standard medical treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in the ratio of PaO2 to FiO2 from baseline
Time Frame
Day 10
Secondary Outcome Measure Information:
Title
PaO2
Time Frame
up to 30 days
Title
blood oxygen saturation (SpO2)
Time Frame
up to 30 days
Title
clinical status rating on the 7-point ordinal scale
Description
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.
Time Frame
up to 30 days
Title
Time to Clinical Improvement (TTCI)
Description
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).
Time Frame
up to 30 days
Title
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use
Time Frame
up to 30 days
Title
Duration (hours) of invasive mechanical ventilation use
Time Frame
up to 30 days
Title
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use
Time Frame
up to 30 days
Title
Duration (days) of Oxygen use
Time Frame
up to 30 days
Title
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment
Time Frame
Day 10
Title
The counts/percentage of Lymphocyte
Time Frame
up to 30 days
Title
Time to hospital discharge with clinical recovery from the randomisation
Time Frame
up to 30 days
Title
The incidence of critical status conversion in 30 days
Description
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.
Time Frame
up to 30 days
Title
All-cause mortality within 30 days
Time Frame
up to 30 days
Title
Frequency of severe adverse drug events
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Shang, M.D.
Organizational Affiliation
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiang-Rong Huang, M.D.
Organizational Affiliation
Yangtze University Health Science Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiao-Dong Li, M.D.
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhong Wang, M.D.
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Wuhan No.7 Hospital/North China University of Science and Technology Affiliated Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Zhongnan Hospital of Wuhan University/Tanshan People's Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430200
Country
China

12. IPD Sharing Statement

Learn more about this trial

Yinhu Qingwen Granula for the Treatment of Severe CoVID-19

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