COVID-19
Conditions
Interventions
Test group 1:FM100mg + VV116 + SOC
Test group 2:FM100mg + SOC
Placebo control group 3:FM placebo + VV116 + SOC
Placebo control group 4:FM placebo + SOC
Extended phase test group 1:FM + VV116 + SOC
Extended phase test group 2:FM + SOC
Extended phase placebo group 3:FM placebo + SOC
Extended phase placebo group 4:FM placebo + SOC
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old, gender unlimited; 2. Inclusion criteria for COVID-19 infection: Coronavirus (COVID-19) was infected within 14 days, and the samples collected 72 hours before enrollment were confirmed by polymerase chain reaction (PCR) or antigen detection (if the detection ability and conditions are limited due to the lack of detection supplies, but it indicates the progressive disease of continuous infection with COVID-19). According to the judgment of the researcher, the condition is aggravated, and any of the following criteria is the criteria for COVID-19 severe patients: (1) Respiratory distress, respiratory rate = 30 times/min; At rest, oxygen saturation 65 years old, who have not completed the whole process of vaccination, and who have more serious chronic diseases (including hypertension, diabetes, coronary heart disease, chronic lung disease, malignant tumors, and low immune function); 3. Patients had progression risk indicators before enrollment: at least one inflammatory index was higher than the upper normal limit value (IL-6, CRP, d-dimer, LDH, ferritin >= ULN) within 2 days; 4. Willing and/or able to follow the procedures and evaluation related to the study; 5. Patients can understand and agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to the test drug and its excipients; 2. They are receiving cytotoxic or biological therapy (such as TNF inhibitor, IL-1 inhibitor, IL-6 inhibitor (Tozumab, Adamumab, etc.), T cell or B cell targeted therapy (rituximab, interferon, etc.), or Janus kinase (JAK) inhibitor, except for this study; 3. Have received plasma of convalescent COVID-19 or intravenous injection of human immunoglobulin; Has received a clear and effective COVID-19 virus neutralizing antibody; 4. In addition to COVID-19 infection, there are other serious infections, such as suspected serious bacterial fungal virus, active pulmonary tuberculosis, NTM, etc.; 5. Known HIV antibody positive, active hepatitis B virus test positive (HBsAg positive, HBV-DNA positive or >= 1000 copies/mL), anti-HCV antibody or HCV-RNA positive; 6. The live vaccine has been vaccinated within 1 week before the screening or is expected to be vaccinated during the study period; 7. Severe liver disease (total bilirubin (TBIL) >= 3 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) >= 5 times the upper limit of normal value); 8. Patients with severe renal insufficiency (glomerular filtration rate <= 30 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis; 9. Blood routine test: neutrophil count < 1.0 x 10^9/L, lymphocyte count < 0.2 x 10^9/L, platelet < 30 x 10^9/L, hemoglobin < 60 g/L; 10. Patients who have absorption disorder syndrome or any other condition that affects gastrointestinal absorption, need intravenous nutrition or cannot take oral medicine; 11. It requires invasive respiratory support or advanced life support, such as ECMO; 12. Patients who have suffered from malignant tumor in the past 5 years and are not controlled at present; 13. Patients who participated in other new drugs or medical devices and took the study drug and used the study device within one month before screening; 14. Pregnant or lactating female patients, fertile female/male patients who refuse to use contraception during the trial and within 6 months after the end of the trial; 15. Have taken strong CYP3A inhibitors (such as ketoconazole, clarithromycin, itraconazole) or strong CYP3A4 inducers (rifampicin) within two weeks before the first administration; 16. Patients with congenital coagulation abnormalities, such as multiple thromboses and hemorrhagic diseases; 17. Alcohol dependence or drug abuse; 18. The researchers believe that the patient's disease progression is going downhill, and it is unlikely to survive for at least 48 hours after screening; Or other factors that are not suitable for the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who died or needed non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) on the 28th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Days in hospital and ICU;For example, SpO2 >= 93 can be reached and maintained for 24 hours without oxygen therapy or indoor oxygen inhalation;COVID-19 Duration of infection-related symptoms;The proportion and time of WHO clinical status rating (from 0 (no virus infection) to 10 (death) decreasing by two levels;Recovery time;Improvement of inflammatory factor level;Nucleic acid conversion time; | — |
Countries
China
Contacts
Public ContactWemin Li
West China Hospital, Sichuan University
Outcome results
None listed