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

• Status: Suspended
• Trial end date: 2023-05-01
• 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 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.

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

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences

Criteria

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.