Trial IRCT20151227025726N24
Publication Tolouian R, J Investig Med, 2021 (published paper)
Dates: 2020-05-06 to 2020-06-20
Funding: No specific funding (The authors have not declared a specific grant for this research from
any funding agency in the public, commercial or not-for-
profit
sectors)
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 at the time of signing the informed consent; chest imaging and clinical symptoms consistent with COVID-19 pneumonia; laboratory (reverse transcription polymerase chain reaction (RT-PCR)) confirmed infection with 2019-nCoV; willingness to participate in the study; no concurrent participation in other clinical trials. |
Exclusion criteria | Pregnancy or lactation; severe liver disease (eg, aspartate aminotransferase (AST)>5 times upper limit); undergoing dialysis or transferred to another hospital within 72 hours; history of allergy to bromhexine. |
Interventions | |
Treatment
Bromhexine hydrochloride 8 mg orally 4 times a day for 2 weeks |
|
Control
Standard care ( / ) Definition of Standard care: Patients received treatment based on the hospital COVID-19 treatment protocol and best practice guidelines in place at that time. (lopinavir/ritonavir) (Kaletra) 400/100 two times per day for 7 days or discharge from hospital and interferon (IFN) beta-1a (Rebif) 44 μg subcutaneous every other day for five doses in addition to supportive and symptomatic therapy. | |
Participants | |
Randomized 111 participants (n1=59 / n2= 52) | |
Characteristics of participants N=111 Mean age : 51.8 46 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=* | |
Primary outcome | |
In the register NR | |
In the report Clinical improvement within 28 days. Clinical improvement was defined as the time (in days) from initiation of the study treatment (active or placebo) until a decline of two categories on a clinical status scale occurred | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
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 |
High |
General comment | Only the published article was used in data extraction and assessment of risk of bias. No protocol or statistical analysis plan was available. The registry was retrospective. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Some outcomes from the registry are not reported in the paper (e.g., change (reduction) in viral load in upper and lower respiratory tract specimen, duration of extracorporeal membrane oxygenation (ECMO)). The study achieved its target sample size. |