A randomized, open-label, blank-controlled, multi-center clinical study for Lian-Hua Qing-Ke Tablets in the treatment of severe novel coronavirus pneumonia
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2100004363
- Lead Sponsor
- Hebei Province Chest Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with confirmed COVID-19 by Pathogen testing;
2. Above 18 years old (inclusive), both male and female;
3. Severe novel coronavirus pneumonia meets one of the following conditions;
(1) Shortness of breath, RR>=30 times/min;
(2) In the resting state, the oxygen saturation is less than or equal to 93% when inhaling air;
(3) Arterial partial pressure of oxygen (PAO 2)/oxygen concentration (FIO 2) <= 300mmHg (1mmHg=0.133kPa);
(4) Patients with progressive clinical symptoms, pulmonary imaging showed significant progression of >50% within 24 ~ 48 hours.
4. Voluntarily sign written informed consent.
1. There is clear evidence of bacterial infection in respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
2. Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory tracts diseases that affecting clinical trial evaluation . Chest CT confirmed that patients with basic pulmonary diseases such as severe pulmonary interstitial lesions and bronchiectasis;
3. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc.;
4. Pregnant or lactating women;
5. Patients who participated in other clinical trials within the last 3 months;
6. An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients of the drug;
7. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is time to clinical improvement (censored at Day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status or live discharge;
- Secondary Outcome Measures
Name Time Method Improvement time of clinical symptoms(disappearance of pulmonary rales, recovery of body temperature, absorption of pulmonary lesions> 50%, recovery of blood picture);Changes of oxygenation index in blood gas analysis (up to 28 days);To turn a standard time in the ICU(up to 28 days);Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens (up to 28 days);Duration (days) of mechanical ventilation (up to 28 days);Duration (days) of supplemental oxygenation (Time Frame: up to 28 days);All cause mortality (up to 28 days);