COVID-19 trials registries data warehouse

http://en.irct.ir/trial/50601

Shahin Merat

shahin.merat@gmail.com

2020-09-11

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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

2

Tehran University of Medical Sciences

18

100

Iran

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

2000

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.

Phase 3

[{"arm_notes": "", "treatment_id": 1478, "treatment_name": "Daclatasvir+sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]