Study to Evaluate the Safety and Efficacy of Sofosbuvir/Daclatasvir in Participants with Moderate to Severe Coronavirus Disease (COVID-19)

• Register: IRCT
• Last refreshed on: 15 June 2020
• Main ID: IRCT20200128046294N2
• Date of registration: 2020-03-14
• Prospective Registration: Yes
• Primary sponsor: Digestive Disease Research Institute
• Public title: Study to Evaluate the Safety and Efficacy of Sofosbuvir/Daclatasvir in Participants with Moderate to Severe Coronavirus Disease (COVID-19)
• Scientific title: 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
• Date of first enrolment: 2020-03-26
• Target sample size: 70
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/46463
• Study type: interventional
• Study design: 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.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr Hossein Poustchi
• Affiliation: Tehran University of Medical Sciences

• Name: Shirin Afhami
• Affiliation: Tehran University of Medical Sciences

Key inclusion & exclusion 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


Age minimum: 18 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

U07.1

COVID-19.
COVID-19

Intervention(s)

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.

Primary Outcome(s)

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 Outcome(s)

Serious adverse events. Timepoint: Any time during study 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.

All-cause mortality. Timepoint: Any time during study up to day 14. Method of measurement: Clinical evaluation.

Requirement for mechanical ventilation. Timepoint: daily up to day 14. Method of measurement: Clinical evaluation.

Source(s) of Monetary Support

Digestive Disease Research Institute

Fannavaran Rojan Mohaghegh Daru

Secondary Sponsor(s)

Fannavaran Rojan Mohaghegh Daru

Ethics review

Status: Approved
Approval date: 11/03/2020
Contact:

Institutional Research Ethics Committee, Vice-Chancellor in Research Affairs- Tehran University of M