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Status:

SUSPENDED

Yinhu Qingwen Granula for the Treatment of Severe CoVID-19

Lead Sponsor:

Zhong Wang

Collaborating Sponsors:

Wuhan Leishenshan Hospital

The First Affiliated Hospital of Dalian Medical University

Conditions:

COVID-19

Severe Pneumonia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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 ma...

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 ma...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2023

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT04310865

Start Date

November 1 2021

End Date

April 1 2023

Last Update

July 7 2021

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital

Wuhan, Hubei, China, 430071

2

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

Wuhan, Hubei, China, 430071

3

Zhongnan Hospital of Wuhan University/Tanshan People's Hospital

Wuhan, Hubei, China, 430071

4

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

Wuhan, Hubei, China, 430200