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IRCT20180302038915N1 IRCT 2021-04-05 Shahid Beheshti University of Medical Sciences Safety and efficacy of sofosbuvir in the moderate COVID19 Evaluation of the Safety and Efficacy of Sofosbuvir in patients with moderate COVID19, A Single-blind, randomized controlled trial 2021-04-14 anticipated 50 Complete https://irct.ir/trial/55052 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: by block randomization technique , allocation of the patients will be completely randomized via using a software. there will be 2 arms, Blinding description: This study will be Single- blinded. Care providers and data analyzers will be blind. 3 COVID19. Intervention 1: Intervention group: all the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted in the COVID ward with definitive moderate COVID19 diagnosis and randomly divided into two arms( each with 50 patients). in the intervention arm, the treatment regimen will consist of sofosbuvir, interferon beta 1a, and national protocol for COVID treatment. interferon beta 1a 44 micrograms will be administered subcutaneously 3-5 doses a day and sofosbuvir 400 mg orally and daily for 10 days and paraclinical tests and vital signs and blood O2 saturation will be assessed according to the plan by experienced health providers. Intervention 2: Control group: All the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted to the COVID ward with definitive moderate COVID19 diagnosis and randomly divided into two arms( each with 50 patients). in the intervention arm, the treatment regimen will consist of interferon beta 1a and national protocol for COVID treatment. interferon beta 1a 44 micrograms will be administered subcutaneously 3-5 doses a day for 10 days and paraclinical tests and vital signs and blood O2 saturation will be assessed according to the plan by experienced health providers. 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 yet , we have not come to conclusion about this
public Fariba Ghorbani
Dr, Masih Daneshvary Hospital, Niavaraan, Daaraabaad,
Tehran Iran (Islamic Republic of) 1416753955 +98 21 2712 2163 dr.f.ghorbani@gmail.com Shahid Beheshti University of Medical Sciences scientific Rama Bozorgmehr
ُShohada Hospital, Shahrdari Aven, Tajrish square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 r.bozorgmehr@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Both genders Age ranging from18 to 80 Y.O. who are admitted in hospital showing at least one of these criteria: Fever (Oral temperature ≥ 38 ℃) , Respiratory rate >24/min , O2Sat<93% in room air or the Pa02/Fi02 ratio ≤300mgHg Laboratory (RT-PCR) confirming the infection with 2019-Covid Virus Lung involvement in CT-Scan less than 50 % ( in compliance with the involvement of moderate COVID19 ) 5 ≤days since onset of the COVID19 symptoms ≤10 18 years 80 years Both History of allergic reaction to the drugs used in this clinical trial in a pregnancy or breast feeding status test Receipt of any experimental treatment for COVID-19 before hand Heart rate < 60/min currently on amiodarone prescription presence of multi organ failure evidence in need of mechanical ventilation estimated glomerular filtration rate < 50 0mL/1.73 m2/min admitted in ICU ward who are in shock U07.1 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: all the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted in the COVID ward with definitive moderate COVID19 diagnosis and randomly divided into two arms( each with 50 patients). in the intervention arm, the treatment regimen will consist of sofosbuvir, interferon beta 1a, and national protocol for COVID treatment. interferon beta 1a 44 micrograms will be administered subcutaneously 3-5 doses a day and sofosbuvir 400 mg orally and daily for 10 days and paraclinical tests and vital signs and blood O2 saturation will be assessed according to the plan by experienced health providers Control group: All the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted to the COVID ward with definitive moderate COVID19 diagnosis and randomly divided into two arms( each with 50 patients). in the intervention arm, the treatment regimen will consist of interferon beta 1a and national protocol for COVID treatment. interferon beta 1a 44 micrograms will be administered subcutaneously 3-5 doses a day for 10 days and paraclinical tests and vital signs and blood O2 saturation will be assessed according to the plan by experienced health providers Time to reach clinical recovery. Timepoint: after 10 days on treatment initiation. Method of measurement: daily physical exam, assessing vanishing of tachypnea ,blood saturation of O2(using pulse-oximeter) , fever( using thermometer). The rate of patients who need to admit in ICU ward. Timepoint: 14 days after Treatment initiation. Method of measurement: physical exam and paraclinical evaluation. The rate of patient expiry in each arm. Timepoint: 14 days after treatment initiation. Method of measurement: questionnaire. Remission of clinical symptoms in each arm. Timepoint: 14 days after treatment initiation. Method of measurement: physical exam ( thermometer and pulse-oximeter). Shahid Beheshti University of Medical Sciences Approved 2021-02-21 Vice-Chancellor in Research Affairs- Shahid Beheshti University of Medical sciences Aarabi st , Evin Tehran Tehran Iran (Islamic Republic of)