French pharmaceutical company conducts the study to compare the efficacy of GNS561 versus standard of care in patients with SARS-CoV-2 (COVID-19)
The pharmaceutical company Genoscience Pharma is conducting the study to compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection (CureCovid-2019).
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.
It is planned to include 178 participants.
Actual study start date is November 18, 2020. The researchers expect to complete the study by October 30, 2021.
The number 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 is primary outcome measure.
Among the exclusion criteria are:
- 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.
- Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
- Pregnant or breastfeeding patient, or expecting to conceive children.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04637828) Genoscience Pharma, Marseille, France, 13006.
