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 Definition of Standard care: Patients received treatment 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. | |
| Participants | |
| Randomized 78 participants (n1=39 / n2= 39) | |
| Characteristics of participants N=78 Mean age : 59.8 43 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=* | |
| 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 stated NR |
| 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. |