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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-12-30

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.

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open-label, controlled, randomized phase 2 study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GNS561 plus standard of care

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.

Group Type EXPERIMENTAL

GNS561

Intervention Type DRUG

study drug

standard of care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GNS561

study drug

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No