Trial IRCT20100228003449N29
Publication Nourian A, Acta Biomed, 2020 (published paper)

Funding: Mixed (Tehran University of Medical Sciences. SOF/LDP donated from Zistdaru Danesh Co.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 14
Inclusion criteriaAdult patients (≥18 years old); highly suspected (according to the clinical signs/symptoms and imaging findings) or confirmed (a positive PCR of pharyngeal or nasopharyngeal samples) COVID-19 who were admitted to medical wards of the hospital
Exclusion criteriaHistory of drug allergy; decompensated cirrhosis; severe COVID-19; patients under hemodialysis; pregnant and lactating women
Interventions
Treatment
Sofosbuvir-ledipasvir ( / )Co-Intervention: Standard care
Duration :
Control
Standard care ( / )
Definition of Standard care: In addition to the supportive care modalities, the standard of care according to the hospital protocol included hydroxychloroquine (HCQ 400 mg BD at first day then 200 mg BD for 7 days) plus atazanavir/ritonavir 300/100 mg daily for 7 days
Participants
Randomized
90 participants (n1=45 / n2= 45)
Characteristics of participants
N=90
Mean age : NR
* males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0
Primary outcome
In the register
Response to the treatment (improvement of patients' chief complaint, abnormal paraclinic and radiologic findings); Gastrointestinal complications; Cutaneous complications; Neurological complications; Renal complications; Hematological complications
In the report
Clinical response; Time to clinical response
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

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 trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The study achieved the target sample size specified in the trial registry. The intervention dose was slightly different in the trial registration compared to the publication. There were some differences in the outcomes reported, the definition of outcomes and outcome timepoint between the published report and the trial registry.