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 |
|
Exclusion criteria |
|
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=* | |
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 avalaible |
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. |
Trial NCT04273763
Publication Li T, Clin Transl Sci (2020) (published paper)
Funding: Public/non profit ( Special Project for Significant New Drug Research and Development in the Major National Science and Technology Projects of China )
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / China Follow-up duration (days): 21 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
Bromhexine 32 mg orally 3 times a day for 14 days |
|
Control
Standard care | |
Participants | |
Randomized participants : Bromhexine=12 Standard care=6 | |
Characteristics of participants N= 18 Mean age : NR 14 males Severity : Mild: n=* / Moderate: n=* / Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Time to clinical recovery after treatment and Rate of aggravation [Time Frame: within 14 days from the start of medication] | |
In the report Clinical recovery and the deterioration rate after initiation of medications | |
Documents avalaible |
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 all available versions of the pre-print article, the study registry was used in data extraction and risk of bias assessment. This is a report of the pilot study of a randomized controlled trial.
Quote: "The number of patients finally included was less than expected due to the successful containment of disease in China." There were some differences from the trial registration in the secondary outcomes. The trial registry reported the intervention treatments as Bromhexine Hydrochloride Tablets, Arbidol Hydrochloride Granules, Recombinant Human Interferon α2b Spray; and the control as Arbidol Hydrochloride Granules and Recombinant Human Interferon α2b Spray. The accepted manuscript reported the intervention arm as Bromhexine Hydrochloride group and the control group as standard of care. All patients received antiviral drugs including arbidol hydrochloride granules and recombinant human interferon α2b spray. A total of 9 patients, 8 from the Bromhexine Hydrochlorid group and 1 from the control group, had treatment duration of less than 14 days because of early cessation with disease recovery. No patient in either group deteriorated during the observation period; all patients in both groups achieved clinical remission and negative SARS-CoV-2 results. |
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 |
|
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=* | |
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 avalaible |
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. |