Official Title
Cure COVID: A Prospective, Controlled, Randomized Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection
Brief Summary

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.

Detailed 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.

Unknown status
COVID-19

Drug: GNS561

study drug

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Genoscience Pharma
Marseille, France

Investigator: Christelle Ansaldi, MD
Contact: +33(4) 91 26 99 50
cansaldi@genosciencepharma.com

Genoscience Pharma
NCT Number
MeSH Terms
COVID-19