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Verification of the efficacy of Bromhexine-hydrochloride in treatment of patients with COVID19 disease

Verification of the efficacy of Bromhexine-hydrochloride in treatment of patients with COVID19 disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200818048444N1
Enrollment
1300
Registered
2020-09-15
Start date
2020-09-22
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19

Interventions

Intervention 1: Intervention group: The intervention group will receive 8 mg bromhexine tablets every 8 hours for 14 days. Intervention 2: Control group: will receive 3 placebo tablets per day for 14

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 18 years and older, both sexes Having home contact, unmasked contact with a patient with Covid-19 confirmed by RT-PCR or clinical evidence or radiography of pneumonia and acute respiratory distress syndrome (ARDS); No clinical signs of Covid-19 (fever, cough, dyspnea, shortness of breath, sore throat, extreme tiredness, digestive problems); No chronic respiratory problems or other illnesses that are mistaken for symptoms of COVID-19

Exclusion criteria

Exclusion criteria: Involvement with any other ongoing studies. Pregnant or breast feeding woman or with positive pregnancy test result for fetal safety Severe liver disease as a strong confounding factor Severe renal failure as a strong confounding factor Refusal by attending physician for no clinical equipoise Advanced active malignancy as a strong confounding factor Patient in other clinical trials for COVID-19 within 30 days before/after ICF as a confounding factor/s Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, severe renal failure, and etc. May impact primary and other clinical endpoints- Known allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications for patient protection purposes Other uncontrolled disease, as judged by investigators that may influence study endpoint and other clinical outcome

Design outcomes

Primary

MeasureTime frame
Test for the presence or absence of nucleic acid in the corona virus. Timepoint: 15 days after the intervention. Method of measurement: real-time PCR.;Serum IgM and IgG levels. Timepoint: 15 days after the intervention. Method of measurement: Immunology test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhalil Ansarin

Tabriz University of Medical Sciences

dr.ansarin@gmail.com+98 41 3337 8093

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026