Trial IRCT20200317046797N4
Publication Ansarin K, BioImpacts (2020) (published paper)
Dates: 2020-04-18 to 2020-05-19
Funding: Public/non profit (Tabriz University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 28
Inclusion criteria
  • Hospital admission, 18 years old or greater, chest imaging and clinical symptoms consistent with COVID-19 pneumonia, willingness to participate in the study, signed informed consent, and no participation in other clinical trials.
Exclusion criteria
  • Pregnancy or lactation, patients with chronic respiratory disease that pre-existence symptoms or consolidations may interfere with an accurate diagnosis of COVID-19, and a history of allergy to bromhexine and patients with cancer.
Interventions
Treatment
Bromhexine
8 mg orally 3 times a day for 2 weeks
Control
Standard care

Participants
Randomized
participants :
Bromhexine=39
Standard care=39
Characteristics of participants
N= 78
Mean age : NR
43 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Hospitalization days, Need for mechanical ventilation, Condition of discharge (death or recovery), Period of mechanical ventilation
In the report
Improvement in the rate of ICU admissions, intubation/mechanical ventilation, and 28-days mortality.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias.
Both groups received standard therapy based on the Iranian national COVID-19 treatment protocol and best practice guidelines at that time and also the “Hydroxychloroquine 200 mg/d for two weeks” in addition to supportive and symptomatic therapy.
The registry's primary outcomes did not reflect the reported primary outcomes. Some outcomes from the registry were not reported in the paper (e.g., period of mechanical ventilation). Secondary outcomes (e.g., number of patients with specific symptoms) were reported in the paper, but were not pre-specified in the trial registry. Target sample size specified in the registry was achieved. There was no change from the trial registration in the intervention and control treatments.