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Safety of Sofosbuvir /Daclatasvir in outpatients with COVID-19

Safety study of Sofosbuvir 800mg and Daclatasvir 120mg in adult outpatients with COVID-19

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200128046294N3
Enrollment
50
Registered
2020-10-22
Start date
2020-10-24
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. Clinical or epidemiological diagnosis of COVID-19 where laboratory confirmation is inconclusive or not available.

Interventions

Intervention group: receiving Sofosbuvir 800mg and Daclatasvir 120mg (two drugs combination of Sofosbuvir 400mg and Daclatasvir 60mg, two tablets per day, Sovodak) produced by :Fanavaran Rojan Mohag

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Both sexes Age higher than 18 years old Diagnosis of COVID 19 Patients that do not need to be admitted in hospital

Exclusion criteria

Exclusion criteria: Patients without consent form Patients that can not come for follow-up Pregnancy , breast feeding Renal insufficiency with eGFR less than 30 , or serum creatinin higher than 2.5 mg/dl in male and 2 mg/dl in female Heart rate less than 50/ min Hepatitis B infection Amiodarone and /or Warfarin consumption

Design outcomes

Primary

MeasureTime frame
Related or non -related adverse events. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Daily follow-up.

Secondary

MeasureTime frame
Time to clinical recovery. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Clinical Follow-up.;Hospitalization. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Clinical follow-up.;Death. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Clinical follow-up.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAnahita Sadeghi

Tehran University of Medical Sciences

anahita825@gmail.com+98 21 8241 5176

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026