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IRCT20151227025726N24 IRCT 2020-11-25 Shahid Beheshti University of Medical Sciences Evaluation of the efficacy and safety of bromhexine administration in COVID-19 Evaluating the efficacy and safety of bromhexine in hospitalized COVID-19 patients 2020-07-10 anticipated 100 Complete https://irct.ir/trial/49043 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We randomize patients at a 1:1 ratio to receive either oral Bromhexine or placebo. Participants will be enrolled by the local principle investigators at site. Consecutively patients will receive a trial number by the principal investigator. Before the trial commences, each trial number will be randomized to a treatment arm by computer (randomization will be done using online website www.sealedenvelope.com/simple-randomiser/v1/lists) The intervention assignment communicates to the principle investigators. The study is double blinded and the trial monitor throughout by the data monitoring committee. Trial recruitment stops after the target study population is reached and will close when all patients complete their follow-up, Blinding description: In this double blind study, patients who received the drug or placebo and physician (researcher) are blinded to the study groups (drug or placebo). Similar labeling will be used for the drug and placebo and only the randomizer will be aware of the study groups. 2-3 COVID-19 pneumonia. Intervention 1: Intervention group: Patients allocated to treatment group were given 8 mg bromhexine tablet (Tolid Daroo), four times a day, orally for 28 days. Patients also received Supportive treatment includes interferon b1a (Resigen) 44 microgram every other day for 3 doses + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Intervention 2: Control group: Control group received placebo (Tolid Daroo), four times a day, orally for 28 days. Patients also received supportive treatment includes interferon b1a (Resigen) 44 microgram every other day for 3 doses + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six months after publishing the results To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers through Email (fzh.dastan@gmail.com). Comments:
public Payam Tabarsi
Shahid Bahonar St., Darabad St
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 payamtabarsi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
Bahonar St., Darabad St.,
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 fzh.dastan@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age ≥18 years at time of signing Informed Consent Form Laboratory (RT-PCR) confirmed infection with COVID-19 Lung involvement confirmed with chest imaging Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio <300mgHg ≤12 days since illness onset Willingness of study participant to accept randomization to any assigned treatment arm Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study 18 years no limit Both Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit) Pregnant or breastfeeding, or positive pregnancy test Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Will be transferred to another hospital which is not the study site within 72 hours Receipt of any experimental treatment for 2019-nCoV (off-label, or trial related) within the 30 days prior to the time of the screening evaluation Allergic to the Bromhexine U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients allocated to treatment group were given 8 mg bromhexine tablet (Tolid Daroo), four times a day, orally for 28 days. Patients also received Supportive treatment includes interferon b1a (Resigen) 44 microgram every other day for 3 doses + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Control group: Control group received placebo (Tolid Daroo), four times a day, orally for 28 days. Patients also received supportive treatment includes interferon b1a (Resigen) 44 microgram every other day for 3 doses + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Time to Clinical Improvement (TTCI). Timepoint: Daily. Method of measurement: TTCI is defined as the time (in days) from initiation of the study treatment (active or placebo) until a decline of two categories from admission status occur.1. Hospital discharge or meeting discharge criteria; 2. Non-ICU hospitalization, not requiring supplemental oxygen; 3. Non-ICU hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 4. ICU/non-ICU hospitalization, requiring NIV/ HFNC therapy; 5. ICU hospitalization, requiring IMV; 6. Death. Need for invasive mechanical ventilation. Timepoint: Daily. Method of measurement: Medical record. Death. Timepoint: At the end of the study. Method of measurement: Medical record. Clinical status. Timepoint: Days 7, 14, 21, 28. Method of measurement: Medical record. Time to hospital discharge. Timepoint: Daily. Method of measurement: Medical record. All-cause mortality. Timepoint: Daily. Method of measurement: Medical record. Duration of mechanical ventilation. Timepoint: Daily. Method of measurement: Medical record. Duration of extracorporeal membrane oxygenation (ECMO). Timepoint: Daily. Method of measurement: Medical record. Duration of supplemental oxygen. Timepoint: Daily. Method of measurement: Medical record. Duration of hospitalization. Timepoint: Daily. Method of measurement: Medical record. Time to RT-PCR negativity in upper and lower respiratory tract specimen. Timepoint: Daily. Method of measurement: Medical record. Change (reduction) in viral load in upper and lower respiratory tract specimen. Timepoint: Daily. Method of measurement: Medical record. Shahid Beheshti University of Medical Sciences Approved 2020-06-30 Ethics Committe of Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)