Back to resultsA Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection (CureCovid-2019)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
GNS561
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
- Genoscience PharmaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GNS561 plus standard of care
standard of care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the 28-day survival rate
the crude proportion of patients still alive 28 days after randomization
the rate of intensive care unit admission
to 14 days from randomization
the rate of nasopharyngeal swab negativation at D7, D14 and D28
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637828
Brief Title
A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection
Acronym
CureCovid-2019
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genoscience Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
open-label, controlled, randomized phase 2 study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GNS561 plus standard of care
Arm Type
Experimental
Arm Description
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.
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GNS561
Intervention Description
study drug
Primary Outcome Measure Information:
Title
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
Description
severe stage at baseline to medium or low stage at day-7 or medium stage at baseline to low stage at day-7
Time Frame
7 days
Secondary Outcome Measure Information:
Title
the 28-day survival rate
Description
the crude proportion of patients still alive 28 days after randomization
Time Frame
28 days
Title
the rate of intensive care unit admission
Description
to 14 days from randomization
Time Frame
14 days
Title
the rate of nasopharyngeal swab negativation at D7, D14 and D28
Time Frame
7 days, 14 days and 28 days
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Genoscience Pharma
City
Marseille
ZIP/Postal Code
13006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle Ansaldi, MD
Phone
+33(4) 91 26 99 50
Email
cansaldi@genosciencepharma.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection
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