Yinhu Qingwen Granula for the Treatment of Severe CoVID-19

NCT04310865 | Suspended Phase 2 DMC

• 1 other identifier: YHQW-Severe-V2.0
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19; Severe Pneumonia; Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• changes in the ratio of PaO2 to FiO2 from baseline

  Day 10

Secondary Outcomes (14)

• PaO2

  up to 30 days

• blood oxygen saturation (SpO2)

  up to 30 days

• clinical status rating on the 7-point ordinal scale

  up to 30 days

• Time to Clinical Improvement (TTCI)

  up to 30 days

• Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use

  up to 30 days

Study Arms (2)

Yinhu Qingwen Granula Group

EXPERIMENTAL

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

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.

Drug: Yin Hu Qing Wen Granula(low does); Other: standard medical treatment

Interventions

Yinhu Qingwen Granula DRUG

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.

Yinhu Qingwen Granula Group

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).

Yinhu Qingwen Granula Low-dose Group

standard medical treatment OTHER

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.

Yinhu Qingwen Granula Group; Yinhu Qingwen Granula 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;
• 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;
• %\> lymphocyte percentage ≥5%;
• No difficulty swallowing oral medications.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhong Wang: lead
• Wuhan Leishenshan Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Tanshan People's Hospital: collaborator
• North China University of Science and Technology: collaborator
• Jizhong Energy Fengfeng Group Hospital: collaborator

Study Sites (4)

Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital

Wuhan, Hubei, 430071, China

Location

Wuhan No.7 Hospital/North China University of Science and Technology Affiliated Hospital

Wuhan, Hubei, 430071, China

Location

Zhongnan Hospital of Wuhan University/Tanshan People's Hospital

Wuhan, Hubei, 430071, China

Location

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

Wuhan, Hubei, 430200, China

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong Shang, M.D.

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

  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

• Zhong Wang, M.D.

  China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 17, 2020
• Study Start: November 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

CN (4)