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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: GNS561


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open-label, controlled, randomized phase 2 study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GNS561 plus standard of care<br>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. | Drug: GNS561<br>* study drug<br>|
| No Intervention: standard of care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | severe stage at baseline to medium or low stage at day-7 or medium stage at baseline to low stage at day-7 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 28-day survival rate | the crude proportion of patients still alive 28 days after randomization | 28 days | 
| the rate of intensive care unit admission | to 14 days from randomization | 14 days | 
| the rate of nasopharyngeal swab negativation at D7, D14 and D28 |  | 7 days, 14 days and 28 days |