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

Sponsor

Genoscience Pharma (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04637828

Collaborator

(none)

178

Enrollment

Location

Arms

13.4

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: GNS561	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

178 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

open-label, controlled, randomized phase 2 studyopen-label, controlled, randomized phase 2 study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

Jul 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

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 [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

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
the rate of nasopharyngeal swab negativation at D7, D14 and D28 [7 days, 14 days and 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genoscience Pharma	Marseille		France	13006

Sponsors and Collaborators

Genoscience Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genoscience Pharma

ClinicalTrials.gov Identifier:

NCT04637828

Other Study ID Numbers:

GNS561-CL-I-Q-0291

First Posted:

Nov 20, 2020

Last Update Posted:

Jul 28, 2021

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 28, 2021