COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001635-27/FR

AB Science - Alain Moussy

DL_MEDICALWRITERS@ab-science.com

2020-04-06

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen ≤72h prior to randomization. 2. Hospitalized patients for the treatment of COVID pneumopathy 3. Patients not requiring invasive intubation at admission with moderate and severe pneumopathy according to the 7-point ordinal scale i.e. 1. Not hospitalized, no limitations on activities, 2.Not hospitalized, limitation on activities, 3. Hospitalized, not requiring supplemental oxygen, 4. Hospitalized, requiring supplemental oxygen, 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6. Hospitalized, on invasive mechanical ventilation or ECMO, 7. Death. Moderate cases (3, and 4 , 7-point ordinal scale) i.e. cases meeting all of the following criteria: Showing fever and respiratory symptoms with radiological findings of pneumonia. Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 >97% Severe cases (score 5, 7-point ordinal scale) i.e. cases meeting any of the following criteria: Respiratory distress (≧30 breaths/ min), Oxygen saturation≤93% at rest in ambient air, or Oxygen saturation ≤97 % with O2 > 5L/min. PaO2/FiO2≦300mmHg 4. Male or non-pregnant female adult ≥ 18 years of age at time of enrolment. 5. Patient with body weight > 45 kg and body mass index (BMI) ≥ 18 and ≤35 kg/m2. 6. Patient must be able and willing to comply with study visits and procedures. 7. Patient agrees to the collection of nasopharyngeal swabs and venous blood per protocol 8. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures. 9. Contraception: - Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during treatment and for 6 months after the last treatment intake - Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during treatment and for 3 months after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake Highly effective and effective methods of contraception are detailed in appendix 19.3 of the protocol.

Participants are excluded from the study if any of the following criteria apply: 1. Recent history of severe cardiovascular disease including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack, edema of cardiac origin and left ventricular ejection fraction ≤ 50%, prolongation of the congenital or acquired QT interval. 2. Patient who had major surgery within 2 weeks prior to screening visit. 3. Patient with known hypersensitivity to masitinib or to any of theirs excipients 4. Patient with severe hepatic impairment defined as hepatic transaminase levels > 5 ULN or total bilirubin level > 1.5 ULN 5. Patient with severe renal impairment defined as a glomerular filtration rate < 30 ml/min/1.73 m2. 6. Patient on treatment for malignancy or with a history of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer. 7. Patient with atopic disease 8. Concomitant use of strong inducer of CYP3A4, substrate of CYP3A4 with narrow therapeutic index. 9. Concomitant treatment with CYP2C8 inhibitors 10. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity. 11. Patient unable to swallow oral treatments 12. Pregnancy and lactation. 13. Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: Absolute neutrophils count (ANC) ≤ 1.5 x 109/L Haemoglobin ≤ 10 g/dL Platelets (PLT) ≤ 100 x 109/L Albuminemia ≤ 1 x LLN 14. Patient with any condition that the physician judges could be detrimental to patient participating in this study, including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions. 15. Patient enrolled in any other therapeutic clinical trial with the same endpoints. 16. Absence of Social Security 17. Patient protected by law under guardianship or curatorship

2

AB Science

18

79

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

50

• Clinical status of patients at day15 using the 7-point ordinal scale. The 7-point ordinal scale for clinical status is: 1. Not hospitalized, no limitations on activities, 2.Not hospitalized, limitation on activities, 3. Hospitalized, not requiring supplemental oxygen, 4. Hospitalized, requiring supplemental oxygen, 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6. Hospitalized, on invasive mechanical ventilation or ECMO, 7. Death.

Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1621, "treatment_name": "Isoquercetin+masitinib", "treatment_type": "Others pharmacological treatment+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]