E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10084268 |
E.1.2 | Term | COVID-19 |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of GNS561 in patients with Covid-19 infection versus standard of care |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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; 6. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment; 7. Women of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test; 8. Women of childbearing potential and male patients must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy;
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E.4 | Principal exclusion criteria |
1. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). 2. Patient requires the use of one of the following forbidden treatment during the study treatment period: • Major surgery. • Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (Flu-Mist®) are live attenuated vaccines, and are not allowed. 3. Any clinically significant cardiovascular condition as judged by the Investigator, like uncontrolled blood pressure, unstable angina, history of myocardial infraction within 6 months, clinically significant peripheral vascular disease 4. Known hepatitis B, treated or not, with viral load < 20 UI/mL or Human Immunodeficiency Virus (HIV) infection, with negative viral load and CD4 > 250/mm3, in last 3 months. 5. Prior allogeneic bone marrow transplantation or solid organ transplant in the past. 6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. 7. 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. |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |