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

NCT04278963 | Suspended Phase 2 DMC

• 1 other identifier: YHQW-V3.0
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

CoVID-19; Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 28 days

Secondary Outcomes (11)

• Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen

  up to 28 days

• Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve.

  up to 28 days

• Time to defervescence (in those with fever at enrolment)

  up to 28 days

• Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)

  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)

  up to 28 days

Study Arms (3)

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.

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.

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.

Other: Chinese medicine treatment; Other: standard western medicine treatment

Interventions

YinHu QingWen Decoction DRUG

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.

Yin Hu Qing Wen Decoction Group

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.

Yinhu Qingwen Decoction low-dose group

Chinese medicine treatment OTHER

This intervention will be given with Chinese medicine decoction granula based on the symptoms differentiation of the patients for 10 days.

Integrated Chinese and Western Medicine group

standard western medicine treatment OTHER

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.

Integrated Chinese and Western Medicine group; Yin Hu Qing Wen Decoction Group; Yinhu Qingwen Decoction low-dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (3)

Jingzhou Hospital of Traditional Chinese Medicine

Jingzhou, Hubei, 434000, China

Location

Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University

Wuhan, Hubei, 430200, China

Location

Xiangyang Hospital of Traditional Chinese Medicine

Xiangyang, Hubei, 441000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 20, 2020
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

CN (3)