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

NCT04637828 | Unknown Phase 2 DMC

• 1 other identifier: GNS561-CL-I-Q-0291
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (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

  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 Outcomes (3)

• the 28-day survival rate

  28 days

• the rate of intensive care unit admission

  14 days

• the rate of nasopharyngeal swab negativation at D7, D14 and D28

  7 days, 14 days and 28 days

Study Arms (2)

GNS561 plus standard of care

EXPERIMENTAL

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

standard of care

NO INTERVENTION

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.

Interventions

GNS561 DRUG

study drug

GNS561 plus standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genoscience Pharma: lead

Study Sites (1)

Genoscience Pharma

Marseille, 13006, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, controlled, randomized phase 2 study

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 20, 2020
• Study Start: November 18, 2020
• Primary Completion: July 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2020-11

Locations

FR (1)