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The effectiveness of Sovodak (sofosbuvir+daclatasvir) in Covid-19 patients

Evaluation of efficacy and safety of Sovodak (Sofosbuvir+Daclatasvir) in combination with Ribavirin for mild to moderate hospitalized Covid-19 patients compared to standard care regimen (a randomized controlled trial)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200328046886N1
Enrollment
48
Registered
2020-04-12
Start date
2020-03-05
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

The effectiveness of Sovodak in patients with novel Corona Virus. ICD-10 code of ‘U07.1 COVID-19, virus identified’ is assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing.

Interventions

Intervention 1: Intervention group: sovodak+ribavirin. Intervention 2: Control group: standard care regimen.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: patients with signing Informed Consent Form Willing Age 18-65 years old Laboratory (RT-PCR) confirmed infection with 2019-nCoV or Lung involvement confirmed with chest CT scan Hospitalized patients with Fever (Oral temperature = 37.8 ?) and at least one of Respiratory rate94% =8 days since illness onset

Exclusion criteria

Exclusion criteria: Known allergic reaction to Sofosbuvir or Daclatasvir Pregnant or breastfeeding women Taking Amiodarone Evidence of multiorgan failure Requiring mechanical ventilation at screening eGFR< 50 mL/min Taking enzyme inducer like Rifampin Receipt of any experimental treatment for COVID-19 prior to the time of the screening Patient with Hb<9

Design outcomes

Primary

MeasureTime frame
Need of invasive and non invasive mechanical ventilation ,need of oxygen supplement , the median time for recovery and well-being. Timepoint: daily in all duration of study. Method of measurement: By designed investigator checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamideh Abbaspour Kasgari

Mazandaran University of Medical Sciences

dr.abbaspour1@yahoo.com+98 11 4203 1035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026