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IRCT20200818048444N4 IRCT 2021-11-28 Tabriz University of Medical Sciences Efficacy of bromhexine-hydrochloride plus hydroxychloroquine on outcome of patients with COVID-19 The effect of the bromhexine-hydrochloride plus hydroxychloroquine on outcome of patients with COVID-19: A randomized, triple-blind, placebo-controlled trial 2021-11-11 anticipated 800 Complete https://irct.ir/trial/59590 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the recruitment of the subject on the basis of the inclusion and exclusion criteria, centralized web-based randomization, through random allocation by balanced block method, individuals are divided into four groups of controls and experimental. Using Random Sequence Generator, groups are created and people are placed in one of these four groups based on the reference sequence, Blinding description: Using placebos and actual drugs blind to the investigator, patient, and care givers except for the person providing drug which is not associated with any of the three. This is a triple blinded study in which the investigator, the patient, and providers of the care all will be blind to the drug received by the patient. The drugs or placebos prepared in 4 similar packages with different codes will be delivered to patient by a member of the team as pharmacist and the data regarding the nature of the packages will not be will be revealed to providers. 3 COVID19. 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 national guideline, one of the four treatments. In GROUP1 the subject will receive bromhexine hydrochloride tablets16 mg every 8 hours for 14 days plus hydroxychloroquine tablets 400mg every 12 hours on day 1 and 200 mg every 12 hours on days 2 to five. Intervention 2: Intervention group 2: 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 national guideline, one of 4 treatments. In GROUP 2 the subject will receive bromhexine hydrochloride tablets16 mg every 8 hours for 14 days plus placebo of hydroxychloroquine tablets for five days. Intervention 3: Intervention group 3: 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 national guideline, one of the four treatments. In the group 3 the subject will receive hydroxychloroquine tablets 400mg every 12 hours at day one and 200 mg every 12 hours at days 2 to five + placebo of bromhexine for 14 days. Intervention 4: Control group: 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 national guideline, one of the four treatments. In the control group (group 4) the individual will receive just placebo for bromhexine hydrochloride for 14 days and hydroxychloroquine for 5 days. Yes - There is a plan to make this available What will be shared: All data can be shared without names of participating subjects When: Summer of 2022 To whom: Researchers can reach the data after their request and approval Conditions: In order to use or control data the researchers should send their request of the data and the data will be delivered to them after approval of their request. Where to obtain: Through the email of: or kansarin@tbxmed.ac.ir or dr.ansarin@gmail.com or the postal code: 5142954481 How to obtain: The researcher should send his/her request of data to our group and data will be sent as a Excel or SPSS file. Comments:
public Khalil Ansarin
Number 24 Gholghasht Street, Azadi Avenue
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 8093 ansarink@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Khalil Ansarin
24 Gholghasht Street, Azadi Avenue
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 8093 imamreza@tbzmed.ac.ir Tabriz University of Medical Sciences and Ministry of health Iran (Islamic Republic of) 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. 18 years no limit Both 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. U07.1 SARS-associated coronavirus as the cause of diseases classified elsewhere CODE: U07.1 Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo 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 national guideline, one of the four treatments. In GROUP1 the subject will receive bromhexine hydrochloride tablets16 mg every 8 hours for 14 days plus hydroxychloroquine tablets 400mg every 12 hours on day 1 and 200 mg every 12 hours on days 2 to five. Intervention group 2: 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 national guideline, one of 4 treatments. In GROUP 2 the subject will receive bromhexine hydrochloride tablets16 mg every 8 hours for 14 days plus placebo of hydroxychloroquine tablets for five days. Intervention group 3: 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 national guideline, one of the four treatments. In the group 3 the subject will receive hydroxychloroquine tablets 400mg every 12 hours at day one and 200 mg every 12 hours at days 2 to five + placebo of bromhexine for 14 days. Control group: 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 national guideline, one of the four treatments. In the control group (group 4) the individual will receive just placebo for bromhexine hydrochloride for 14 days and hydroxychloroquine for 5 days. 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. Tabriz University of Medical Sciences Approved 2021-10-25 Regional Committee for Research Ethics(Human Subject Studies(91000001)) Third Floor, Tabriz University of Medical Sciences, Central Building Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)