Yinhu Qingwen Granula for the Treatment of Severe CoVID-19

• Status: Suspended
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.