COVID-19 pneumonia
Conditions
Interventions
Treatment group:Conventional western medicine treatment+Fuzheng Jiedu granule
Control group:Conventional western medicine treatment
Sponsors
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meet diagnostic criteria of severe-to-critical COVID-19 pneumonia according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9); 2. Aged from 18 to 85; 3. Initial onset of signs/symptoms attributable to COVID-19 or Confirmed SARS-CoV-2 infection as determined by RT-PCR or other means within 5 days prior to the day of randomization; 4. Informed consent signed by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to experimental medicine; 2. Patients with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Patients with a known medical history of active liver disease (including chronic or active hepatitis B infection, primary biliary cirrhosis, acute liver failure etc.); 4. Receiving dialysis or having known renal failure [ie, eGFR <15 mL/min/1.73 m2 of the screening visit, using the serum creatinine-based CKD-EPI formula]; 5. Severe primary diseases of the hematopoietic system (leukemia, myelodysplastic syndrome, idiopathic thrombocytopenia, etc.); 6. Patients with uncured malignant tumors; 7. Patients with known immunodeficiency, such as organ or bone marrow transplantation, HIV infection, or immunosuppressant use in the last 3 months; 8. Patients who have participated in other clinical trials within 3 months before inclusion in the study; 9. Pregnant or lactating women; 10. Patients with a high rate of within 24 hours or death is inevitable, regardless of what treatment; 11. Patients who cannot cooperate with the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with progression of disease severity at 7 days/14 days/28 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of composite events (Severe case including ICU admission, MODS, shock, death, deterioration to critical type, etc.; Critical case including MODS, shock, death, etc.);Rate/Frequency of tracheal intubation and Invasive mechanical ventilation;Rate/Frequency of High-flow nasal cannula oxygen therapy or non-Invasive mechanical ventilation;Oxygenation index;Frequency of complication;Rate of ICU admission;Length of hospital stay;Proportion of patients with improvment of disease severity at 7 days/14 days/28 days;28-day mortality;Changes in inflammatory markers (CRP, PCT, IL-6,); | — |
Countries
China
Contacts
Public ContactZhang Zhongde
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed