A prospective, randomized,open, multi-center clinical trial evaluating the efficiency and safety of Reduning injection in the treatment of novel coronavirus pneumonia (COVID-19)
- Conditions
- novel coronavirus pneumonia (COVID-19)
- Registration Number
- ITMCTR2000002972
- Lead Sponsor
- Beijing hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Comply with the diagnostic criteria of Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Version 5);
(2) The classification was judged as common and severe type;
(3) Having one or more symptoms of fever, cough and fatigue when entering the group;
(4) The diagnosis time does not exceed 48 hours;
(5) Aged >= 18 years.
(1) Immunodeficiency diseases, or those using immunosuppressive agents or glucocorticoids within the past 3 months;
(2) Pregnancies, pregnant women and lactating women;
(3) An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients in this test);
(4) Psychotic patients, or those without self-knowledge ability;
(5) Patients whose estimated survival time does not exceed 48 hours from the start of screening;
(6) Tracheal intubation and mechanical ventilation have been performed during screening;
(7) Other problems that doctor's judgment is not suitable for the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical symptom recovery rate;
- Secondary Outcome Measures
Name Time Method Antipyretic time;clinical symptom disappearance time;improvement rate of chest CT;28-day survival rate;The disappearance time and disappearance rate of individual symptoms such as fever and cough;Time and rate of virus turning negative;Length of hospital stay;Severe conversion rate;Laboratory tests (leukocyte, lymphocyte count, neutrophil count, C-reactive protein, erythrocyte sedimentation rate, D-dimer improvement);