Trial *
Publication Sali S, Novelty in Biomedicine, 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 criteriaAge above 18;
Hospitalized;
Fever (Oral temperature ≥ 38 °C);
At least one of the following - a respiratory rate more than 24/min or an O2 Saturation level less than 93% or the PaO2/ FiO2 ratio lower than 300;
Confirmed PCR for the nuclide acid of SARS-COV-2 in a nasopharyngeal swab specimen or a chest lung CT scan compatible with COVID-19 patterns
Exclusion criteriaDissatisfaction with being included in or continuing the study;
Having a known allergic reaction to interventional drugs;
Pregnancy or breastfeeding;
Any prior experimental treatments for COVID-19;
Heart rate less than 60/min;
Taking amiodarone;
Evidence of multiorgan failure;
Requiring mechanical ventilation at the screening;
eGFR of less than 50 ml/min
Interventions
Treatment
Hydroxychloroquine+Sofosbuvir
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
Control
Hydroxychloroquine+Lopinavir-Ritonavir ( / )
Participants
Randomized
54 participants (n1=22 / n2= 32)
Characteristics of participants
N=54
Mean age : 57.1
29 males
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0
Primary outcome
In the register
NR
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

Unclear
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.