NCT05415241

Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of COVID-19 Close Contacts

Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of Close Contacts of COVID-19 Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Close Contact Transmission

Interventions

Type	Name	Description
DRUG	FB2001	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.

Timeline

• Start date: 2022-06-09
• Primary completion: 2022-08-09
• Completion: 2022-12-31
• First posted: 2022-06-13
• Last updated: 2022-06-13