Trial IRCT20200403046926N1
Publication Roozbeh F, J Antimicrob Chemoth (2020) (published paper)
Dates: 2020-04-08 to 2020-05-19
Funding: Public/non profit (Mazandaran University of Medical Sciences)
Conflict of interest: Yes
Methods | |
RCT Blinding: | |
Location :
Single center / Iran Follow-up duration (days): 30 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Sofosbuvir-Daclatasvir Sofosbuvir 400 mg + Daclatasvir 60 mg, orally once a day for 7 days. |
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Control
Standard care | |
Participants | |
Randomized participants : Sofosbuvir-Daclatasvir=30 Standard care=30 | |
Characteristics of participants N= 60 Mean age : NR 26 males Severity : Mild: n= 55/ Asymptomatic: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Symptoms ending (during the study); Lymphopenic Status (up to day 7); C-reactive protein Status (up to day 7); Saturation of Peripheral Oxygen (up to day 7) | |
In the report Symptom alleviation by Day 7 | |
Documents available |
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 |
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General comment | In addition to the published article, the study registry was used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved. There were some differences in the primary outcomes included in the registry and those reported in the published article. The study did not report any of the outcomes included in the COVID NMA analyses. Authors will be contacted to provide relevant data. |