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

• ClinicalTrials.gov Identifier: NCT04637828
• Recruitment Status: Unknown
• First Posted: November 20, 2020
• Last Update Posted: July 28, 2021
• Sponsor: Genoscience Pharma
• Information provided by (Responsible Party): Genoscience Pharma

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 (Clinical Trial)
• Estimated Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: open-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: November 18, 2020
• Estimated Primary Completion Date: July 30, 2021
• Estimated Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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 :

1. the 28-day survival rate [ Time Frame: 28 days ]
   the crude proportion of patients still alive 28 days after randomization
2. the rate of intensive care unit admission [ Time Frame: 14 days ]
   to 14 days from randomization
3. the rate of nasopharyngeal swab negativation at D7, D14 and D28 [ Time Frame: 7 days, 14 days and 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: 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.
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

France

Genoscience Pharma; Recruiting

Marseille, France, 13006

Contact: Christelle Ansaldi, MD +33(4) 91 26 99 50 cansaldi@genosciencepharma.com

Sponsors and Collaborators

Genoscience Pharma

More Information

• Responsible Party: Genoscience Pharma
• ClinicalTrials.gov Identifier: NCT04637828
• Other Study ID Numbers: GNS561-CL-I-Q-0291
• First Posted: November 20, 2020
• Last Update Posted: July 28, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases