COVID-19
Conditions
Interventions
Test group:Recombinant human anti COVID-19 monoclonal antibody nasal spray (F61 nasal spray)
placebo group:Recombinant human anti COVID-19 monoclonal antibody nasal spray placebo (F61 nasal spray placebo, normal saline)
Sponsors
Wuhan Infectious Diseases Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years (including threshold) or above; 2. Close contact people who have been exposed to SARS CoV-2 infected persons within 72 hours; 3. Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures within 6 months from signing the informed consent to the administration of the study drug; 4. Subjects can understand the research content and voluntarily sign the informed consent form; At the same time, the research can be completed according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1. Confirmed cases, suspected cases or positive nucleic acid test of novel coronavirus pneumonia; 2. (Interview) People with a history of AIDS; 3. (Interview) Suspected or confirmed active systemic infection except COVID-19; 4. (Interview) Have a history of hypersensitivity or other contraindications to any component of the study intervention; 5. (Interview) Those who have received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid treatment within 5 years before screening; 6. (Interview) Those who have participated in clinical trials of other drugs and have received trial drugs within 3 months before screening (the last visit time of the last trial is calculated from the start time); 7. Pregnant or lactating women, or positive urine pregnancy test results during screening period; 8. (Interview) Those with acute nasal mucosa injury, erosion, ulcer and tumor; 9. (Interview) Those who have undergone sinus surgery or have nasal trauma that has not yet fully healed within 3 months before screening; There are local fungal, bacterial, viral or parasitic infections on the face that are not cured and still need continuous treatment within 4 weeks before screening; 10. The researcher thinks it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protective effect of single nasal spray on SARS CoV-2 infection within 5 days; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Infectious Diseases Hospital
Outcome results
None listed