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

NCT05415241 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Frontier Biotechnologies Inc.

    collaborator INDUSTRY

  • Shanghai Center for Disease Control and Prevention

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2022-08-09
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415241 on ClinicalTrials.gov