Condition 1: COVID-19. Condition 2: COVID-19. COVID-19, virus identified COVID-19, virus not identified
Conditions
Interventions
Intervention 1: Intervention group: Receiving Bromhexine 8 mg 3 times a day for 14 days in patients with history of close contact to confirmed COVID-19 in past 4 days. Intervention 2: Control group: R
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Sistanizad
Shahid Beheshti University of Medical Sciences
Outcome results
None listed