Trial *
Publication Sali S, Novelty in Biomedici (2021) (published paper)
Funding: Public/non profit (Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences)
Conflict of interest: *
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Iran Follow-up duration (days): * | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
HCQ+SOF HCQ: 200 mg twice a day (every 12 hours) orally for 7 to 14 days SOF: 400 mg per day orally for 7 to 14 days |
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Control
HCQ+LPV/r HCQ: 400 mg stat orally for 7 to 14 days LPV/r: 400/100 mg twice a day (every 12 hours) orally for 7 to 14 days | |
Participants | |
Randomized participants : HCQ+SOF=22 HCQ+LPV/r=32 | |
Characteristics of participants N= 54 Mean age : NR 29 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register NR | |
In the report NR | |
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 |
Some concerns |
General comment | Only the published article was used in data extraction and assessment of risk of bias. The study protocol, statistical plan, and trial registry were not available. The study achieved the planned sample size reported in the methods section. There is some question about the number of patients included in the final analysis. The article reports that the “number of patients from groups A and B who withdrew from the study were 3 and 2, respectively (Table-3)”. Yet Table 3 does not report withdrawals, and these numbers equate to the numbers of deaths in these arms. It is believed this is likely a translation error. Groups were imbalanced regarding PCR positive test results (HCQ+LPV/r vs HCQ+SOF: 100% vs 50%); spiral chest CT scan consistent with COVID-19 for all patients. The overall follow-up of the study (including the timepoint at which mortality data were collected) and the primary outcome were not reported. |