Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection

• Status: Recruiting
• Trial end date: 2021-01-22
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating COVID-19 infection. After the enrolment of approximately 30 subjects, the recruitment will be paused, and planned interim analysis will be performed to preliminarily investigate the efficacy and safety of TCMs in patients infected with COVID-19.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing 302 Hospital
• Treatments: Antiviral Agents; Interferon-alfa-1b; Interferon-alpha; Interferons; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Confirmed COVID-19 infection case in term of laboratory evidence;

• 80 years ≥ age ≥ 14years;

• Within 72 hours after the onset of abnormalities shown by Chest radiology or several symptoms (fever and cough).

Exclusion Criteria:

• Age < 14 years or > 80 years;

• Pregnant or lactating female;

• One of the following items occurred at the enrollment: (i) respiratory failure necessitating mechanical ventilation; (ii) liver failure: total bilirubin ≥ 10mg/dL and/or severe coagulation disorders; (iii) renal function failure: although adequate circulating blood and cardiac output, urine ≤ 0.5ml/kg·h, Cr or BUN ≥ 1.5 times normal elevation;

• Intake of Chinese medicinal herbs during the past 2 weeks;

• Refused to sign an informed consent form prior to study participation;

• Unwilling and unable to comply with protocol request.