COVID-19 trials registries data warehouse

http://en.irct.ir/trial/49043

Afshin Zarghi

mpd@sbmu.ac.ir

2020-11-25

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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

2

Shahid Beheshti University of Medical Sciences

18

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Time to Clinical Improvement (TTCI) Need for invasive mechanical ventilation Death

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 240, "treatment_name": "Bromhexine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]