This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.
Patients will be treated either with oral GNS561 plus standard of care or only standard of care. All patients in experimental arm will be treated for ten days. Study drug will be provided as oral capsules containing 200 mg of GNS561. Patients will be followed-up during hospitalization and after discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
study drug
Genoscience Pharma
Marseille, France
RECRUITINGnumber and proportion of participants, per randomized group, with a loss of one or two grades of National Early Warning Score (NEWS2) score at day-7 compared to baseline
severe stage at baseline to medium or low stage at day-7 or medium stage at baseline to low stage at day-7
Time frame: 7 days
the 28-day survival rate
the crude proportion of patients still alive 28 days after randomization
Time frame: 28 days
the rate of intensive care unit admission
to 14 days from randomization
Time frame: 14 days
the rate of nasopharyngeal swab negativation at D7, D14 and D28
Time frame: 7 days, 14 days and 28 days
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