A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection (CureCovid-2019)

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: GNS561

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 Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13006
    • Recruiting
    • Genoscience Pharma
    • Contact: Christelle Ansaldi, MD; Phone Number: +33(4) 91 26 99 50; Email: cansaldi@genosciencepharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GNS561; study drug
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genoscience Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GNS561-CL-I-Q-0291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No