A randomized, double-blind, multicenter, placebo-controlled phase II clinical study to evaluate the efficacy and safety of F61 injection in the treatment of patients with mild/common novel coronavirus pneumonia (COVID-19)

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2022
INTERVENTION: Test group 1:F61 injection 600mg;Test group 2:F61 injection 900mg;Control group 1:F61 placebo 600mg;Control group 2:F61 placebo 900mg; CONDITION: Diseases caused by the new coronavirus PRIMARY OUTCOME: Time from baseline to continuous negative conversion of severe acute respiratory syndrome coronavirus type 2 (SARS CoV‐2) in swab samples (preferred nasopharyngeal swab); 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 stu
Epistemonikos ID: cd90704ae98cd750dc03fb1d469901d5643d081f
First added on: Nov 25, 2022