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 criteria
  • Adult 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 criteria
  • History of drug allergy
  • decompensated cirrhosis
  • severe COVID-19
  • patients under hemodialysis
  • pregnant and lactating women
Interventions
Treatment
SOF/LDP
400/100 mg orally once daily for 10 days
Control
Standard care

Participants
Randomized
participants :
SOF/LDP=45
Standard care=45
Characteristics of participants
N= 90
Mean age : NR
0 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
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 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
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.