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IRCT20200831048568N1 IRCT 2020-09-11 Tehran University of Medical Sciences Efficacy of sofosbuvir and daclatasvir in ambulatory patients with coronavirus disease SODACAN A Multicentre, Quadruple-blind, Randomized, Parallel-group Study to Compare the Efficacy of Sofosbuvir and Daclatasvir vs. Placebo in the Outpatient Treatment of COVID-19 in adults 2020-09-10 anticipated 2000 Complete https://irct.ir/trial/50601 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to either SOF/DAC or control group with a 1:1 allocation using a central computer-generated randomisation schedule at DDRI in blocks of 4. The study drug and placebo will be packed in DDRI and labelled with a trial registration number according to the randomization table. No information on the randomization schedule or any data on the contents of drug packs will be available to researchers or patients at recruitment sites, Blinding description: Enrolling physician, patient, researchers who assess outcomes and statistician will be blinded. 3 COVID-19. Intervention 1: Intervention group: A single daily tablet containing sofosbuvir 400mg and daclatasvir 60mg (Sovodak, Fanavaran Rojan Mohaghegh Daru Co., Tehran, Iran) for 10 days. Intervention 2: Control group: A single daily tablet containing placebo (similar to sovodak, Fanavaran Rojan Mohaghegh Daru Co., Tehran, Iran) for 10 days. 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 Ali Ali Asgari
Shariati hospital, Jalal Al Ahmad
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8241 5000 aliasgari@tums.ac.ir Tehran University of Medical Sciences scientific Ali Ali Asgari
Shariati hospital, Jalal Al Ahmad
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2101 aliasgari@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult patients (≥18 years) Onset of any one of the following symptoms within 7 days before presentation: fever, cough, chest discomfort, dyspnea, loss of taste or smell, severe body aches, weakness or fatigue Laboratory-confirmed SARS-CoV-2 infection by qualitative Reverse transcription polymerase chain reaction (RT-PCR) Able to provide written, informed consent Able to comply with study protocol for follow-up Not requiring hospitalization at the time of recruitment 18 years no limit Both Personal history of COVID-19 Pregnancy or breastfeeding Known severe chronic kidney disease requiring dialysis or eGFR <30 Taking medications that interfere with trial drugs including amiodarone or warfarin Heart rate <50 / min Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation U07.1 COVID-19 confirmed by laboratory testing Treatment - Drugs Treatment - Drugs Intervention group: A single daily tablet containing sofosbuvir 400mg and daclatasvir 60mg (Sovodak, Fanavaran Rojan Mohaghegh Daru Co., Tehran, Iran) for 10 days. Control group: A single daily tablet containing placebo (similar to sovodak, Fanavaran Rojan Mohaghegh Daru Co., Tehran, Iran) for 10 days. Difference between the two treatment arms in the proportion of participants classed as treatment failure at 14 days from enrolment. Treatment failure is defined as need for hospital admission or all-cause mortality within 14 days. Need for hospital admission is defined as the decision of a physician to admit the patient to a hospital according to current national COVID-19 guidelines issued by the ministry of health. However, if the participant leaves the hospital against medical advice, it will still be considered a treatment failure. Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. Time to hospitalization (days from enrolment). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. Duration of hospital stay (days). Timepoint: One month after enrolment. Method of measurement: Clinical follow-up. Need for ICU stay according to hospital records (yes/no). Timepoint: One month after enrolment. Method of measurement: Clinical follow-up. Need of mechanical ventilation according to hospital records (yes/no). Timepoint: One month after enrolment. Method of measurement: Clinical follow-up. Time to complete symptom resolution [patient becomes asymptomatic] from start of treatment (days from enrolment). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. Hospital ER visit at the discretion of the patient (yes/no). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. Adverse drug effects (yes/no). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. International Treatment Preparedness Coalition Approved 2020-08-15 Digestive Diseases Research Institute- Tehran University of Medical Sciences Shariati hospital, Jalal Al Ahmad Tehran Tehran Iran (Islamic Republic of)