IRCT20200128046294N2
Completed
Phase 3
A prospective randomized controlled trial comparing Sovodak (Sofosbuvir plus Daclatasvir) in participants with moderate to severe Coronavirus disease (COVID-19) compared to standard of care treatment
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Digestive Disease Research Institute
- Enrollment
- 70
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both genders
- •Age \=18 years at time of signing Informed Consent Form
- •Willing and able to provide written informed consent prior to performing study to any assigned treatment arm
- •Must agree not to enroll in another study of an investigational agent prior to completion of study
- •Will be admitted to Shariati hospital (Tehran), Baharloo (Tehran), Sina (Tehran), Sayyad Shirazi (Gorgan) and not transferred to another hospital
- •Laboratory (RT\-PCR) confirmed infection with 2019\-nCoV
- •Lung involvement confirmed with chest CT scan
- •Hospitalized patients with: Fever (Oral temperature \= 37\.8 ?) and at least one of Respiratory rate \>24/min / O2Sat\<94% or the Pa02/Fi02 ratio \<300mgHg
- •\=8 days since illness onset
Exclusion Criteria
- •Known allergic reaction to Sofosbuvir or Daclatasvir
- •Pregnant or breastfeeding, or positive pregnancy test
- •Receipt of any experimental treatment for COVID\-19 prior to the time of the screening evaluation
- •Heart rate \< 60/min
- •Taking Amiodarone
- •Evidence of multiorgan failure
- •Requiring mechanical ventilation at screening
- •eGFR\< 50 mL/min
Outcomes
Primary Outcomes
Not specified
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