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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001635-27 | EudraCT Number |
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Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) that is associated with substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19.
Many patients with moderate and severe COVID-19, develop a "cytokine storm" that leads to severe pulmonary inflammation and various thrombotic events associated with acute respiratory distress syndrome (ARDS) and potentially death. The combination of masitinib and isoquercetin may prevent the development of these two complications. Masitinib is a potent blocker of mast cells and macrophages that are contributors to the cytokine storm. Isoquercetin inhibits disulfide isomerase (PDI), an enzyme directly involved in the formation of clots, and also decreases D-Dimer, a predictor of COVID-19 thrombosis severity.
The primary objective of this study is to evaluate efficacy of the masitinib and isoquercetin combination in moderate and severe COVID-19 patients. The primary endpoint is subject clinical status at day 15, using a 7-point ordinal scale that is defined as follows: 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masitinib plus Isoquercetin plus Best Supportive Care | Experimental | Patients will receive oral masitinib dose of 3 mg/kg/day for 4 days then 4.5 mg/kg/day. The dose of isoquercetin will be 1 g/day by oral route. Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs, or biologics drugs. |
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| Best Supportive Care | Active Comparator | Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs, or biologics drugs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masitinib | Drug | Masitinib is a small molecule drug that selectively inhibits specific tyrosine kinases such as colony-stimulating factor 1 receptor (CSF1R), c-Kit, LYN, FYN, and platelet-derived growth factor receptor (PDGFR) α and β, in the submicromolar range. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status of patients at day-15 using a 7-point ordinal scale | Ordinal scale defined as follows: 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. | 15 days |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Coordinator | Contact | +33(0)147200014 | clinical@ab-science.com |
| Name | Affiliation | Role |
|---|---|---|
| Pascal Chanez, MD | Department of Respiratory Diseases, Aix-Marseille University, Marseille, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier du Pays d'Aix | Recruiting | Aix-en-Provence | France | |||
| Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37117213 | Derived | Durojaye OA, Okoro NO, Odiba AS, Nwanguma BC. MasitinibL shows promise as a drug-like analog of masitinib that elicits comparable SARS-Cov-2 3CLpro inhibition with low kinase preference. Sci Rep. 2023 Apr 28;13(1):6972. doi: 10.1038/s41598-023-33024-2. | |
| 36048877 | Derived | Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1. |
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| Isoquercetin | Drug | Isoquercetin is a flavonoid, derivative of quercetin. Isoquercetin is rapidly hydrolyzed to quercetin. |
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| Best Supportive Care | Drug | Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs or biologics drugs. |
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| Recruiting |
| Bordeaux |
| France |
| CHU Clermont-Ferrand: Site Gabriel-Montpied | Recruiting | Clermont-Ferrand | France |
| Hopital Nord, AP-HM | Recruiting | Marseille | France |
| CHR Orleans, Hopital de la Source | Recruiting | Orléans | France |
| Hopital Larrey, CHU du Toulouse | Recruiting | Toulouse | France |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C526575 | masitinib |
| C016527 | isoquercitrin |
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