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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GNS561 plus standard of care | Experimental | 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. |
|
| standard of care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNS561 | Drug | study drug |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genoscience Pharma | Recruiting | Marseille | 13006 | France |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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open-label, controlled, randomized phase 2 study
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| 14 days |
| the rate of nasopharyngeal swab negativation at D7, D14 and D28 | 7 days, 14 days and 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |