]>
IRCT20200128046294N2 IRCT 2020-03-14 Digestive Disease Research Institute Study to Evaluate the Safety and Efficacy of Sofosbuvir/Daclatasvir in Participants with Moderate to Severe Coronavirus Disease (COVID-19) 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 2020-03-26 anticipated 70 Complete https://irct.ir/trial/46463 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized in a 1:1 ratio into one of the treatment groups and standard of care group using computer generated randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method, Blinding description: The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes and the statistician analyzing the data all will be blinded. 3 COVID-19. 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 oral tablet containing 400mg of Sofosbovir and 60mg of Daclatasvir plus Standard of care treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr Hossein Poustchi
Shariati Hospital, Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8241 5000 h.poustchi@gmail.com Tehran University of Medical Sciences scientific Shirin Afhami
Shariati Hospital, Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2557 afhamish@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Control group: Standard of care treatment according to the national guidelines for the treatment of COVID-19 Intervention group: Sovodak, Company: Rojan, Daily single oral tablet containing 400mg of Sofosbovir and 60mg of Daclatasvir plus Standard of care treatment 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. 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. Fannavaran Rojan Mohaghegh Daru Digestive Disease Research Institute Fannavaran Rojan Mohaghegh Daru Approved 2020-03-11 Institutional Research Ethics Committee, Vice-Chancellor in Research Affairs- Tehran University of M Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)