COVID-19 trials registries data warehouse

http://en.irct.ir/trial/46784

Afshin Zarghi

zarghi@sbmu.ac.ir

2020-04-05

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Written informed consent prior to performing study procedures (SARS-CoV)-2 infection confirmed (PCR) test ≤ 4 days before randomization Currently hospitalized with fever Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening Radiographic evidence of pulmonary infiltrates

Participation in any other clinical trial of an experimental treatment for COVID-19 Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing Evidence of multi-organ failure Requiring mechanical ventilation at screening Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) Creatinine clearance <30mL/min pregnant woman or man who his spouse is pregnant Coadministration of amiodarone, HIV Protease Inhibitors, rifabutin or rifapentine , phenobarbital or oxcarbazepine

2

Shahid Beheshti University of Medical Sciences

18

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Temperature( < 36.6 °C armpit, or < 37.2 °C oral, ) without using antipyretic drugs sustained for at least 72 hours Spo2>= 94% (at room air) sustained for at least 72 hours without Oxygen therapy

Phase 2

[{"arm_notes": "400 mg for 5 days", "treatment_id": 1219, "treatment_name": "Sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400 mg for 10 days", "treatment_id": 1219, "treatment_name": "Sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]