A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection (CureCovid-2019)

Genoscience Pharma

Status and phase: Unknown; Phase 2

Conditions: COVID-19

Treatments: Drug: GNS561

Study type: Interventional

Funder types: Industry

Identifiers

NCT04637828

GNS561-CL-I-Q-0291

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory).
• Clinical status: Hospitalized for moderate COVID-19 with News2 score between 5 and 6

Exclusion criteria

• Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, tafenoquine, hydroxychloroquine, mefloquine).
• History of QT prolongation (QTc ≥ 500 ms) or QTc ≥ 500msec at screening or bradycardia < 50/mn
• Current use of loop diuretics and potassium supplementation or documented history of hypokalemia or hypokalemia < 3.5mmol/l at screening
• Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
• Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

GNS561 plus standard of care

Experimental group

Description:

All patients in this Arm will be treated with 200mg oral capsule of GNS561, once a day, for 10 days and with any necessary measures based on the patient's condition and at the investigator's discretion and routine practices.

Treatment:

Drug: GNS561

standard of care

No Intervention group

Description:

All patients in this Arm will be treated with any necessary measures based on the patient's condition and at the investigator's discretion and routine practices.