COVID-19
Conditions
Interventions
Treatment group:Conventional western medicine treatment+Traditional Chinese medicine
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) Performed with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). (5) Informed consent signed by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: (1) Patients allergic to experimental medicine. (2) Patients with known medical history of active liver disease (including chronic or active hepatitis B infection, primary biliary cirrhosis, acute liver failure etc.). (3) Receiving dialysis or have known renal failure [ie, eGFR <15 mL/min/1.73 m2 of the screening visit, using the serum creatinine-based CKD-EPI formula]. (4) Severe primary diseases of the hematopoietic system (leukemia, myelodysplastic syndrome, idiopathic thrombocytopenia, etc.). (5) Patients with uncured malignant tumors. (6) Patients with known immunodeficiency, such as organ or bone marrow transplantation, HIV infection, or immunosuppressant use in the last 3 months. (7) Patients who have participated in other clinical trials within 3 months before inclusion in the study. (8) Pregnant or lactating women. (9) Patients with high rate of within 24 hours or death is inevitable, regardless of what treatment. (10) Patients who cannot cooperate with the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day /14-day /28-day mortality;Frequency of composite events (including MODS, shock, death,etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of composite events (including MODS, shock, death,etc.);Oxygenation index;Frequency of complication;Length of ICU stay;Time of High-flow nasal cannula oxygen therapy or mechanical ventilation;Proportion of patients with improvment of disease severity at 7 days/14 days/28 days;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