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| Column | Value |
|---|---|
| Trial registration number | IRCT20200818048444N4 |
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Full text link
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
imamreza@tbzmed.ac.ir |
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Registration date
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2021-11-28 |
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Recruitment status
Last imported at : May 1, 2022, 4:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
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Study design
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
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Allocation
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
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Design
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
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Masking
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
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Center
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
single-center |
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Study aim
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Treatment |
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Inclusion criteria
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
COVID19 diagnosis by a physician on the basis of history and physical examination and compatible imaging and PCR testing as: 1, Having symptoms of COVID19 disease: FEVER (measured or subjective), COUGH, DYSPNEA, DIFFICULTY BREATHING, SORE THROAT, NEW OLFACTORY OR TASTE DISORDERS, SEVERE LASSITUDE OR FATIGUE, MYALGIAS, HEADACH, GI SYMPTOMS plus having compatible imaging or positive PCR testing for SARS virus COVID19 2, Being free of chronic respiratory or other illnesses with symptoms confused with symptoms of COVID19 disease AND 3 , Signed consent form. |
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Exclusion criteria
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Major Exclusion Criteria: --1-1- Age: less than 18 years; justification: adult hospital with not enough young patients to compare and follow up 2- Pregnant or breast feeding woman: for fetal safety 3- Severe liver disease and severe renal failure: being confounding - 4- Serious eye disease with visual loss or cardiac conduction defects: as a confounder in side effects of drugs. 5- Subjects on immune modulating drugs for other diseases for: as confounding 6- Subjects already on bromhexine hydrochloride or hydroxychloroquine. 7- Subjects with history of allergy to bromhexine hydrochloride or hydroxychloroquine. 8- Subjects in other clinical trials for COVID-19 within 30 days before or after this trial: for being confounding. 9- Direct admission of patient to ICU at the the time of screening: because of the conflict with one of outcomes. 10- Having other subject characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, severe renal failure, malignancies, and etc.) that may impact primary and other clinical endpoints. 11-Impending death at the time of admission on the judgement of physician. 12- Other uncontrolled disease, as judged by investigators influencing study endpoints. |
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Number of arms
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
4 |
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Funding
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Tabriz University of Medical Sciences |
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Inclusion age min
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
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Inclusion age max
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
100 |
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Countries
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
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Type of patients
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
800 |
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primary outcome
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
ICU transfer Intubation and mechanical ventilation Survival or death of the patient |
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Notes
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Phase
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 3 |
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Arms
Last imported at : Nov. 28, 2021, 11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "", "treatment_id": 1545, "treatment_name": "Bromhexine+hydroxychloroquine", "treatment_type": "Respiratory agents+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 240, "treatment_name": "Bromhexine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}] |