Evaluation of a combination of Masitinib and Isoquercetin in the Treatment of Hospitalized COVID-19 Patients.
- Conditions
- Hospitalized Moderate and Severe COVID-19 PatientsMedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001635-27-ES
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR =72 hours prior to randomization.
2. Patients with:
Moderate COVID-19 of score 4 of the 7-point ordinal scale and requiring between 3 L/min and 6 L/min of oxygen to maintain SpO2 =92% at both screening and baseline.
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.
3. Male or non-pregnant female adult = 18 years of age at time of enrolment.
4. Patient must be able and willing to comply with study visits and procedures.
5. Patient agrees to the collection of nasopharyngeal swabs and venous blood per protocol.
6. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures.
7. Contraception:
- Female patient of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause), 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. Patient with a weight < 45 kg and a BMI < 18 or > 35 kg/m² at screening or at baseline.
2. Patients with current or history of severe cardiovascular disease:
• Myocardial infarction
• Unstable angina pectoris
• Coronary revascularization procedure
• Congestive heart failure of NYHA Class III or IV
• Stroke, including a transient ischemic attack
• Second degree or third-degree atrioventricular block not successfully treated with a pacemaker
• Bi-fascicular block
• QTc Fridericia interval > 450 milliseconds for males and > 470 milliseconds for females
• Drug induced heart failure or ischemic heart disease
• Radiotherapy induced cardiomyopathy
• Family history of unexpected death of cardiovascular origin.
• Edema of cardiac origin and left ventricular ejection fraction = 50%
3. Patients with two or more of the risk factors listed below assessed as High Risk (calculated SCORE = 5% and < 10%), or Very High Risk (calculated SCORE =10%) according to the Systematic Coronary Risk Estimation (SCORE):
- Hypertension (uncontrolled)
- Diabetes
- Kidney disease
- Current tabagism = 10 Pack-year = equivalent to 1 pack of 20 cigarettes for 10 years with the formula N (number of packs of 20 cigarettes smoked daily) x T (number years smoking). Patients who stopped smoking 6 months prior to evaluation are not concerned.
- Hypercholesterolemia
- COPD
This assessment is done according to the Systematic Coronary Risk Estimation (SCORE) using the country specific free full version of HeartScore (if country specific version is not available, EU one will be used), the interactive tool for predicting and managing the risk of heart attack and stroke in Europe, available at https://www.heartscore.org/en_GB/access.
4. Any use of anti-viral medications up to 7 days before participating in the study, including a) Hydroxychloroquine b) Chloroquine c) Remdesivir.
5. Patient who had major surgery within 2 weeks prior to screening visit.
6. Patient who has been exposed to an investigational treatment within 3 months prior to screening.
7. Patient with known hypersensitivity to masitinib or to any of theirs excipients.
8. Patient with severe hepatic impairment defined as hepatic transaminase levels > 5 ULN or total bilirubin level > 1.5 ULN.
9. Patient with pre-existing severe renal impairment, or with abnormal laboratory results at screening:
• Creatinine clearance <60 mL/min (Cockcroft and Gault formula) or
• Proteinuria >30 mg/dL (1+) on dipstick; in case of the proteinuria =1+ on the dipstick, 24 hours proteinuria must be >1.5 g/24 hours.
10. Patient on treatment for malignancy or with a history of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer.
11. Concomitant use of drugs with narrow therapeutic index that are substrate of BCRP or P-gp.
12. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity.
13. Patient unable to swallow oral treatments.
14. Pregnancy and lactation.
15. Patient with any of following laboratory results
• Absolute neutrophils count (ANC) < 1.5 x 109/L
• Haemoglobin < 10 g/dL
• Platelets (PLT) < 75 x 109/L
• Albuminemia < 28g/L
16. 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.
17. Patients with active severe infection such as viral hepatits, human immunodeficiency virus infection.
1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method