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 |
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Exclusion criteria |
|
Interventions | |
Treatment
Bromhexine 8 mg orally 4 times a day for 2 weeks |
|
Control
Standard care | |
Participants | |
Randomized participants : Bromhexine=59 Standard care=52 | |
Characteristics of participants N= 111 Mean age : NR 46 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=* Number of vaccinated participants: NR | |
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 willing stated in the publication: 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 |
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. |