COVID-19 patients
Conditions
Interventions
Intervention group:F61 injection
Control group:N/A
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be included in the study, subjects must meet all of the following conditions: (1) age >= 18, male or female; (2) The test result of SARS-CoV-2 RT-qPCR is positive; (3) Classified as severe type according to the tenth trial edition of the Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol issued by the National Health Commission of the People's Republic of China (NHC); (4) Subject (including partner) has no pregnancy planning within 6 months after signing informed consent to study drug administration; (5) The subject is able to communicate well with the investigator, understand and comply with the requirements of the study, and understand and sign the ICF.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Subjects will not be included in this study if they meet any of the following conditions: Disease: (1) The severity of the disease was divided into mild, moderate and critically severe patients; (2) Suspected or confirmed severe, active bacterial, fungal, viral or other infections (other than COVID-19) that investigators believe may pose a risk when taking interventions; (3) One of the following conditions occurred during the screening period :1)ALT or AST> 3xULN; 2)eGFR <60 mL/min; (4) known allergy to the test drug and its components; Prior/concomitant therapy (5) Participated in other drug clinical trials within 3 months before screening; (6) Other factors considered inappropriate to be included in this study. Other exclusion criteria (7) Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who became critically severe within 14 days after first follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality within 7, 14, 30 days after first follow-up;Time from first follow-up to death;Time from first follow-up to discharge;Time from first follow-up to discharge from the ICU;Proportion of patients receiving vasoactive agents, renal replacement therapy, non-invasive mechanical ventilation, invasive mechanical ventilation, and ECMO within 14 days after first follow-up;Duration of invasive mechanical ventilation, oxygen therapy, vasoactive agents, renal replacement therapy within 14 days after initial follow-up;Duration of period of consecutive negative results for SARS-CoV-2 RT-qPCR after the first follow-up;Percentage of subjects whose SARS-CoV-2 RT-qPCR test result turned negative within 7 and 14 days after the first follow-up;Changes in SARS-CoV-2 RT-qPCR Ct values from baseline on day 7 and 14;Changes in pulmonary CT from baseline at day 7 and 14;Changes in the scoring of the World Health Organization (WHO) 10-point scale of disease progression from baseline on day 7 and 14;Changes in Acute Physiology and Chronic Health Status Assessment II (APACHE II) and Sequential Organ Failure (SOFA) score from baseline on day 7 and 14;Changes in leukocyte count, platelet count, bilirubin, creatinine, D-dimer, lymphocyte count, interleukin 6 (IL-6), C-reactive protein (CRP), ferritin, and the oxygenation index from baseline at days 7 and 14;Incidence and severity of treatment emergent adverse events (TEAE) and serious adverse events (SAEs) during treatment; | — |
Countries
China
Contacts
Public ContactHongping Qu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed