COVID-19. COVID-19
Conditions
Interventions
Intervention 1: Control group: Standard of care treatment according to the national guidelines for the treatment of COVID-19. Intervention 2: Intervention group: Sovodak, Company: Rojan, Daily single
Sponsors
Digestive Disease Research Institute
Fannavaran Rojan Mohaghegh Daru
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical recovery (composite) within 14 days from initiation of study treatment until normalization of fever (=37.2 °C oral), respiratory rate (=24/minute on room air), and oxygen saturation (=94% on room air), sustained for at least 24 hours. Timepoint: daily up to 14 days after starting the trial. Method of measurement: Clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement for mechanical ventilation. Timepoint: daily up to day 14. Method of measurement: Clinical evaluation.;Radiological changes. Timepoint: day 14 or sooner at the discretion of the physician. Method of measurement: Chest CT scan.;Serious adverse events. Timepoint: Any time during study up to day 14. Method of measurement: Clinical evaluation.;All-cause mortality. Timepoint: Any time during study up to day 14. Method of measurement: Clinical evaluation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Hossein Poustchi
Tehran University of Medical Sciences
Outcome results
None listed