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

Primary Purpose

CoVID-19, Chinese Medicine

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
YinHu QingWen Decoction
YinHu QingWen Decoction(low dose)
Chinese medicine treatment
standard western medicine treatment
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment 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. 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.

Sites / Locations

  • Jingzhou Hospital of Traditional Chinese Medicine
  • Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
  • Xiangyang Hospital of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Yin Hu Qing Wen Decoction Group

Yinhu Qingwen Decoction low-dose group

Integrated Chinese and Western Medicine group

Arm Description

Based on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days.

Based on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen
Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve.
Time to defervescence (in those with fever at enrolment)
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)
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)
Frequency of requirement for supplemental oxygen or non-invasive ventilation
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.
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.
Proportion of re-hospitalization or admission to ICU
All-cause mortality
Frequency of serious adverse events

Full Information

First Posted
February 19, 2020
Last Updated
July 4, 2021
Sponsor
China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04278963
Brief Title
Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19
Official Title
Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Suspended
Why Stopped
There were no eligible patients in the paticipated centers.
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences

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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yin Hu Qing Wen Decoction Group
Arm Type
Experimental
Arm Description
Based on the standard western medicine treatment, the patients will be given Yinhu Qingwen Decoction (Granula) for 10 days.
Arm Title
Yinhu Qingwen Decoction low-dose group
Arm Type
Placebo Comparator
Arm Description
Based on the standard western medicine treatment, the patients will be given 10% dose of Yinhu Qingwen Decoction (Granula) for 10 days.
Arm Title
Integrated Chinese and Western Medicine group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
YinHu QingWen Decoction
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
YinHu QingWen Decoction(low dose)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chinese medicine treatment
Intervention Description
This intervention will be given with Chinese medicine decoction granula based on the symptoms differentiation of the patients for 10 days.
Intervention Type
Other
Intervention Name(s)
standard western medicine treatment
Intervention Description
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 Measure Information:
Title
Mean clinical recovery time (hours)
Description
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).
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen
Time Frame
up to 28 days
Title
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
Title
Time to defervescence (in those with fever at enrolment)
Time Frame
up to 28 days
Title
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)
Time Frame
up to 28 days
Title
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
Title
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time Frame
up to 28 days
Title
Frequency of respiratory progression
Description
Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Time Frame
up to 28 days
Title
Severe case incidence
Description
Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Time Frame
up to 28 days
Title
Proportion of re-hospitalization or admission to ICU
Time Frame
up to 28 days
Title
All-cause mortality
Time Frame
up to 28 days
Title
Frequency of serious adverse events
Time Frame
up to 28 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. 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Organizational Affiliation
Jingzhou Hospital of Traditional Chinese Medicine
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
Facility Information:
Facility Name
Jingzhou Hospital of Traditional Chinese Medicine
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434000
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
Facility Name
Xiangyang Hospital of Traditional Chinese Medicine
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441000
Country
China

12. IPD Sharing Statement

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

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