COVID-19
Conditions
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.
Interventions
DRUGGNS561
study drug
Sponsors
Genoscience Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, controlled, randomized phase 2 study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 7 days | severe stage at baseline to medium or low stage at day-7 or medium stage at baseline to low stage at day-7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the 28-day survival rate | 28 days | the crude proportion of patients still alive 28 days after randomization |
| the rate of intensive care unit admission | 14 days | to 14 days from randomization |
| the rate of nasopharyngeal swab negativation at D7, D14 and D28 | 7 days, 14 days and 28 days | — |
Countries
France
Outcome results
None listed