Diseases caused by the new coronavirus
Conditions
Interventions
Test group 1:F61 injection 600mg
Test group 2:F61 injection 900mg
Control group 1:F61 placebo 600mg
Control group 2:F61 placebo 900mg
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At the time of signing ICF, the subjects were = 18 years old, male or female; 2. The test result of SARS CoV-2 nucleic acid was positive; 3. According to the Diagnosis and Treatment Plan for novel coronavirus Pneumonia issued by the National Health Commission (NHC) of the People's Republic of China, the ninth version of clinical classification was tentatively implemented for patients with mild/ordinary type; 4. COVID-19 symptoms <= 7 days before randomization, such as fever, cough, sore throat, nasal congestion/runny nose, headache, muscle pain, shortness of breath/dyspnea, nausea, chills/chills, vomiting, diarrhea, etc.; 5. Within 6 months from the signing of the informed consent to the administration of the study drug, the subjects (including their partners) had no pregnancy plan and voluntarily took effective contraceptive measures; 6. The subjects can communicate well with the researchers, understand and comply with the requirements of this study, understand and sign ICF.
Exclusion criteria
Exclusion criteria: 1. COVID-19 severe patients meet any of the following conditions: (1) Shortness of breath, respiratory rate >= 30 times/min; (2) In the resting state, it refers to the blood oxygen saturation (SpO2) 3 times ULN; 2)eGFR <60 mL/min 11. Any one of hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody is positive; 12. Participated in clinical trials of other drugs within 3 months before screening; 13. Difficulty in venous blood collection or needle and blood sickness; 14. Pregnant and lactating women; 15. Other factors that the researcher thinks are not suitable for this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from baseline to continuous negative conversion of severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2) in swab samples (preferred nasopharyngeal swab); | — |
Countries
China
Contacts
Public ContactHongzhou Lu
Shenzhen Third People's Hospital
Outcome results
None listed