Trial IRCT20201124049480N1
Publication Asgardoon M, ResearchSquare (2021) (preprint)
Dates: 2021-04-15 to 2021-09-15
Funding: Public/non profit (AJA University of Medical Sciences)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Iran Follow-up duration (days): 14 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Levamisole 50 mg/day orally for ten days |
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Control
Standard care | |
Participants | |
Randomized participants : Levamisole=253 Standard care=254 | |
Characteristics of participants N= 507 Mean age : NR 201 males Severity : Mild: n= 507/ Asymptomatic: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register the general condition of the patient Timepoint Days 1,2,3,4,14,28 Method of measurement Visual Analogue Scale(VAS) | |
In the report self-reported general health condition of the participants measured by VNS on days 3,5,7,9,14. | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication: 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 |
Some concerns |
General comment | “In addition to the published article, the prospective study registry was used in data extraction and risk of bias assessment. No protocol or statistical analysis plan were available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome method of measurement (VAS) does not reflect the reported primary outcome measurement method (VNS). Secondary outcomes in the paper had different time points that those specified in the registry. The study (n=507) achieved the target sample size (n=250) specified in the trial registry." |