Bromhexine hydrochloride for prophylaxis against COVID-19

Phase 3

• Conditions: Condition 1: COVID-19. Condition 2: COVID-19.; COVID-19, virus identified; COVID-19, virus not identified; U07.1; U07.2

• Registration Number: IRCT20120703010178N22
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Exposure and close contact (defined as being within 6 feet for a period of 15 minutes or more in a 24 hour period or 5 minutes or more for healthcare associated exposure) to a COVID-19 case within 4 days before entering the study
must agree not to enroll in another investigational study prior to completion of Day 14 of study
Individuals who have the ability to understand and desire to sign the informed consent
Age of 18 years or more

Exclusion Criteria

Current Hospitalization
Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
Hypersensitivity to bromhexine or any component of the formulation
Low risk in individuals in close contact (wearing face mask and eye shield)
Individuals with exposure of less than 15 minutes
Receipt of any medication for prophylaxis and treatment of 2019-nCoV
Patients with any related sign and symptoms of COVID-19

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of COVID-19 disease. Timepoint: At day 14. Method of measurement: Clinical assessment.;Ordinal Scale of COVID-19 disease severity. Timepoint: Censored at Day 14. Method of measurement: Clinical assessment.

Secondary Outcome Measures

Name	Time	Method
Hospitalization or death. Timepoint: Day 14. Method of measurement: Phone call.;Confirmed COVID-19 diagnosis. Timepoint: Day 14. Method of measurement: Self report.;Sign and Symptoms compatible with COVID-19. Timepoint: day 14. Method of measurement: Self report.;Treatment withdrawal or discontinuation. Timepoint: day 14. Method of measurement: self report.