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: double blinding
Location : Single center / Iran
Follow-up duration (days): 30
Inclusion criteriaAdults with confirmed CT scan findings for COVID-19; typical COVID-19 clinical symptoms including fever, cough and fatigue; positive C-reactive protein test
Exclusion criteriaOxygen saturation less than 93%; pregnancy; amiodarone use; renal failure; cardiovascular diseases
Interventions
Treatment
Sofosbuvir-Daclatasvir
Sofosbuvir 400 mg + Daclatasvir 60 mg, orally once a day for 7 days.
Control
Standard care
Definition of Standard care: All patients received standard care according to the national Iranian treatment guidelines. All patients received azithromycin capsules (500mg for 6 days) with naproxen tablets (500mg, twice daily for 7 days), as well as 40mg pantoprazole tablets and hydroxychloroquine (200 mg twice daily for 7 days).
Duration : 7 days
Participants
Randomized
60 participants (n1=30 / n2= 30)
Characteristics of participants
N=60
Mean age : NR
26 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
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 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
*
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.