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

Phase 2

• Conditions: COVID-19
• Interventions: Drug: GNS561

• Registration Number: NCT04637828
• Lead Sponsor: Genoscience Pharma

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study Start: 2020-11-18
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Primary Completion: 2021-07-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GNS561 plus standard of care	GNS561	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
the rate of nasopharyngeal swab negativation at D7, D14 and D28	7 days, 14 days and 28 days
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

Trial Locations

Locations (1)

Genoscience Pharma; 🇫🇷 Marseille, France