Cure COVID: a study to compare the efficacy of GNS561 versus standard treatments in patients with SARS-CoV-2 (COVID-19) infection

INTERVENTION: Product Code: GNS561 Pharmaceutical Form: Capsule, hard CONDITION: COVID‐19 infection ; MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID‐19 System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of GNS561 in patients with Covid‐19 infection versus standard of care Primary end point(s): Loss of one grade of NEWS2 score at day‐7: from medium stage at baseline, to low grade at day‐7 Secondary Objective: The secondary objectives will be to evaluate in each arm of the study:; ‐ the safety of GNS561 in patients with COVID‐19 infection.; ‐ the efficacy of GNS561 in viral replication; ‐ the efficacy of GNS561 on immunity of patients to fight the virus; ‐ the efficacy of GNS561 on the inflammatory reaction induced in patients; Timepoint(s) of evaluation of this end point: Day 7 SECONDARY OUTCOME: Secondary end point(s): ‐ Loss of one grade of NEWS2 score at day‐14; ‐ 28‐day survival rate; ‐ rate of intensive care unit admission to 14‐days from randomization. Clinical status at D7, D14, D28, D44 and D60; ‐ Mean change in clinical status from baseline to days 7, 14, 28, 44 and 60; ‐ Incidence of non‐invasive positive pressure ventilation or heated high flow nasal cannula use; ‐ Incidence of non‐invasive positive pressure ventilation or heated high flow nasal cannula use; ‐ rate of secondary infection by other documented pathogens; ‐ biological parameters ; ‐ safety profile; ‐ length of stay in Intensive Care Unit ; ‐ duration of mechanical ventilation or high flow oxygen devices; ‐ duration of hospitalisation; Timepoint(s) of evaluation of this end point: Day 7, 14, 28, 44 and 60 INCLUSION CRITERIA: 1. Age 18 or older at the time of enrolment. 2. Documented diagnosis of COVID‐19 (diagnostic test performed in a certified laboratory) which is preferable. However if limited access to the test, symptoms of COVID‐19 associated with “lung imaging findings” on chest CT scan: unilateral or bilateral ground‐glass opacities and/or consolidation. 3. Clinical status: News2 score from 5 to 6. 4. Adequate bone marrow and end��organ function defined by the following laboratory results: • Bone marrow: ‐ Hemoglobin = 7.0 g/dL, ‐ Absolute Neutrophils Count (ANC) = 1.0 Gi/L, ‐ Platelets = 100 Gi/L; • Hepatic function: ‐ Total serum bilirubin = 1.5 x ULN (except patients with Gilbert’s syndrome who must have total serum bilirubin = 3.0 x ULN), ‐ AST and ALT = 5 ULN • Renal function: ‐ Serum creatinine = 2.0 x ULN or Cr. Cl. = 30ml/min/1.73m² (MDRD or CKD‐EPI formula); 5. Willingness and ability to comply with the study requirements;

Epistemonikos ID: 38edad225545fff0f4145f0b23f8e58cd0a67286
First added on: Oct 15, 2021