Efficacy of bromhexine-hydrochloride plus hydroxychloroquine on outcome of patients with COVID-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2021
INTERVENTION: 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. CONDITION: COVID19. ; SARS‐associated coronavirus as the cause of diseases classified elsewhere CODE: U07.1 U07.1 PRIMARY OUTCOME: 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. 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.
Epistemonikos ID: dccb9806f93601d0a786d7dc9e0a5b6a40fe05f3
First added on: Nov 29, 2021