COVID-19 patients
Conditions
Interventions
Intervention group:recombinant human anti COVID-19 monoclonal antibody injection (F61 injection)
Control group:F61 placebo
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 nucleic acid is positive; (3) According to the ninth 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), the clinical classification of patients was moderate type; (4) There is at least one severe risk factor:1. Age = 60; 2. Patients with underlying diseases: cardiovascular and cerebrovascular diseases, chronic lung diseases, diabetes, chronic liver and kidney diseases, tumors and other; 3. Immune dysfunction (AIDS, long-term use of corticosteroids or other immunosuppressive drugs resulting in reduced immune function); 4.Obesity (body mass index =30); 5. heavy smokers; 6. Not vaccinated against COVID-19; 7. Stay in a nursing home or nursing institution for a long time. (5) COVID-19 symptoms, such as fever, cough, sore throat, nasal congestion, headache, muscle pain, dyspnea, nausea, chills, vomiting, diarrhea, etc; (6) Subject (including partner) has no pregnancy planning within 6 months after signing informed consent to study drug administration; (7) 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, severe and critical 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) Patients who received SARS-CoV-2-specific immunoglobulin (including monoclonal antibody) treatment 3 months before screening; (6) Patients with a history of receiving convalescent COVID-19 plasma therapy 3 months before administration; Previous/current clinical research experience (7) Participated in other drug clinical trials within 3 months before screening; (8) Other factors considered inappropriate to be included in this study. Other exclusion criteria (9) Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who became severe or above within 8 days of randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality at days 8 to 15 after randomization;Time from randomization to sustained clinical recovery (within 8 days);Percentage of subjects with sustained clinical recovery at days 3, 5, and 8;Duration of negative transformation of SARS-CoV-2 nucleic acid from randomization to 8 days;Percentage of subjects whose SARS-CoV-2 turned negative at days 3, 5 and 8;Change in symptom score (total score) from baseline at days 3, 5, and 8;Change from baseline on the World Health Organization (WHO) 10-point scale of disease progression at days 3, 5, and 8;Changes in Ct values of SARS-CoV-2 nucleic acid detection from baseline at day 3, 5 and 8;Changes in lung CT from baseline at day 3 and 8;Changes in SARS-CoV-2 viral load from baseline in swab samples (nasopharyngeal swabs preferred) at days 3, 5, and 8;Changes in leukocytes, D-dimers, lymphocytes, interleukin 6 (IL-6), C-reactive protein (CRP), and ferritin from baseline at days 3, 5, and 8;Incidence and severity of 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