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.
Drug: Masitinib
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.
Other Name: AB1010
Drug: Isoquercetin
Isoquercetin is a flavonoid, derivative of quercetin. Isoquercetin is rapidly hydrolyzed to quercetin.
Other Name: Array
Drug: Best Supportive Care
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.
Other Name: BSC
Inclusion Criteria:
- Has laboratory-confirmed SARS-CoV-2 infection
- Hospitalized patients for the treatment of COVID pneumopathy
- Patients not requiring ICU at admission with moderate and severe pneumopathy according
to the OMS Criteria of severity of COVID pneumopathy.
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux
Bordeaux, France
CHU Clermont-Ferrand: Site Gabriel-Montpied
Clermont-Ferrand, France
Hopital Nord, AP-HM
Marseille, France
CHR Orleans, Hopital de la Source
Orléans, France
Hopital Larrey, CHU du Toulouse
Toulouse, France
Clinical Study Coordinator
+33(0)147200014
clinical@ab-science.com
Pascal Chanez, MD, Principal Investigator
Department of Respiratory Diseases, Aix-Marseille University, Marseille, France