This is a single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of FB2001 as post-exposure prophylaxis among close contacts of COVID-19 patients. This study will enroll 20 to 60 close contacts of COVID-19 patients aging 18 to 65 years. After signing the informed consent form, the qualified subjects will be given FB2001 once or twice daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Stage 1 (Exploring the dose): Twenty participants will be enrolled for aerosol inhalation of FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, another twenty participants will be enrolled for aerosol inhalation of FB2001 BID for 5 consecutive days. Stage 2 (Sample size expansion): Another twenty participants will be enrolled for aerosol inhalation of FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1.
efficacy index of post-exposure prophylaxis against COVID-19
The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 7 days post inhalation of FB2001.
Time frame: 7 days post aerosol inhalation of FB2001
efficacy index of post-exposure prophylaxis against COVID-19
The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 14 days post inhalation of FB2001.
Time frame: 14 days post aerosol inhalation of FB2001
safety index
The number of cases of intolerance or anaphylaxis, as well as the incidence of treatment-related adverse events (TRAEs) during aerosol inhalation therapy.
Time frame: during aerosol inhalation of FB2001 or 30 minutes (or longer, if necessary) post aerosol inhalation of FB2001
Yanping Xu, PhD
CONTACT
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