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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637828
• Other study ID #: GNS561-CL-I-Q-0291
• Status: Recruiting
• Phase: Phase 2
• Start date: November 18, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2020
• Source: Genoscience Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Drug:
• GNS561
study drug

Locations

Country	Name	City	State
France	Genoscience Pharma	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Genoscience Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the 28-day survival rate	the crude proportion of patients still alive 28 days after randomization	28 days
Secondary	the rate of intensive care unit admission	to 14 days from randomization	14 days
Secondary	the rate of nasopharyngeal swab negativation at D7, D14 and D28		7 days, 14 days and 28 days