Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Efficacy and Safety of Jinhua Qinggan Granules (JHQG) for the Treatment of COVID-19 Patients.
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2000003697
- Lead Sponsor
- Center for Bioequivalence Studies and Clinical Research,Beijing Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Aged 18-75 years male and female;
2. Confirmed Coronavirus infection by real time RT-PCR;
3. Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned in 7.1.2);
4. The subject has signed the informed consent form.
1. Patients with moderate or critical Coronavirus infection confirmed by real time RT-PCR (rRT-PCR); cases meeting any of the following criteria:
(1) Lung lesions;
(2) Respiratory failure and requiring mechanical ventilation;
(3) Shock;
(4) With other organ failure that requires ICU cares;
2. Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system (above grade II of cardiac function; ALT & AST are 1.5 times higher than the normal value; Creatinine above the upper limit of normal value) and mental illness or serious diseases affecting their survival, such as cancer or AIDS;
3. With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency;
4. Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit (including ß2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.);
5. Allergic individuals and those who are known to be allergic to experimental drugs;
6. Pregnant women, lactating women or fertile women who are ready to conceive in 3 months;
7. Subject, who has participated in the past 1 month in another clinical study;
8. Subjects who are not suitable for the clinical trial based on investigators judgment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change (improvement) in clinical signs and symptoms;Negative test time for SARS-CoV2 on RT-PCR;
- Secondary Outcome Measures
Name Time Method Observation of body temperature: The onset time of fever and the complete time of defervescence.;Quality of Life Criterion;Chang in white blood cells, C-reactive protein and ferritin.;Change in radiographic findings of the lungs.;