COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002249-40/FR

Genoscience Pharma - Clinical trials information

contact@genosciencepharma.com

2020-05-01

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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,

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.

2

Genoscience Pharma

18

100

France

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

120

Loss of one grade of NEWS2 score at day-7: from medium stage at baseline, to low grade at day-7

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": null, "treatment_id": 549, "treatment_name": "Gns561", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]