Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

COVID-19 Clinical Trial

Official title:

Randomized, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib Combined With Isoquercetin, and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622865
• Other study ID #: AB20001
• Secondary ID: 2020-001635-27
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: AB Science
• Contact: Clinical Study Coordinator
• Phone: +33(0)147200014
• Email: clinical[@]ab-science.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• COVID-19
• SARS-CoV 2

Intervention

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) a and ß, in the submicromolar range.
• Isoquercetin
Isoquercetin is a flavonoid, derivative of quercetin. Isoquercetin is rapidly hydrolyzed to quercetin.
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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