COVID19. SARS-associated coronavirus as the cause of diseases classified elsewhere CODE: U07.1
Conditions
Interventions
Intervention 1: After selection and enrolment and after obtaining and informed consent subjects will be assigned to one of four groups to to receive, in addition to the usual care as directed by natio
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU transfer. Timepoint: 28 days after the start of the disease. Method of measurement: Patient hospital medical record.;Intubation and mechanical ventilation. Timepoint: 28 days after the start of the disease. Method of measurement: Patient hospital medical record.;Survival or death of the patient. Timepoint: 28 days after start of the disease. Method of measurement: Patient hospital medical record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhalil Ansarin
Tabriz University of Medical Sciences
Outcome results
None listed