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Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients

Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200624047908N1
Enrollment
1000
Registered
2020-07-05
Start date
2020-07-13
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

COVID-19. U07.1

Interventions

Intervention 1: Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days. Intervention 2: Control group: Country Standard Pharmaceutical Protoc

Sponsors

Abadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age =18 One of the following signs: Fever = 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea CT appearance compatible with COVID O2 Saturation 94% or less

Exclusion criteria

Exclusion criteria: Renal failure (eGFR < 30) Bradycardia (HR < 50) Taking amiodarone Previous sofosbuvir use Pregnancy/lactation Multi-organ failure on admission (2 organs or more, excluding lung) Requiring intubation on admission Significant arrhythmia in EKG Allergy to sofosbuvir or daclatasvir Not consenting to the study

Design outcomes

Primary

MeasureTime frame
Recovery within 10 days of starting the drug. Recovery means: (no fever, no shortness of breath, no cough or improved, no fatigue or improved, tolerated oral nutrition) for 24 hours. Timepoint: Daily. Method of measurement: Clinical observation and examination.

Secondary

MeasureTime frame
Recovery within 14 days from start of medication. Timepoint: Daily. Method of measurement: Clinical observation and examination.;Rate of survival. Timepoint: Daily. Method of measurement: census report.;Days admitted in hospital. Timepoint: Daily since hospitalization time. Method of measurement: Based on patient's file.;Days intubated/under ventilator. Timepoint: Daily. Method of measurement: observation.;Days admitted in ICU. Timepoint: Daily. Method of measurement: Based on patient's file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamali Eslami

Abadan University of Medical Sciences

gholamali.eslami1351@gmail.com+98 61 5326 5362

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 14, 2026