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

NCT04622865 | Unknown Phase 2 DMC FDA Drug

• 2 other identifiers: AB200012020-001635-27
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Masitinib; Drug: Isoquercetin; Drug: Best Supportive Care

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.

Drug: Best Supportive Care

Interventions

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.

Also known as: AB1010

Masitinib plus Isoquercetin plus Best Supportive Care

Isoquercetin DRUG

Isoquercetin is a flavonoid, derivative of quercetin. Isoquercetin is rapidly hydrolyzed to quercetin.

Also known as: quercetin-3-O-glucoside, isotrifoliin

Masitinib plus Isoquercetin plus Best Supportive Care

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.

Also known as: BSC

Best Supportive Care; Masitinib plus Isoquercetin plus Best Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• AB Science: lead

Study Sites (6)

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

RECRUITING

Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux

Bordeaux, France

RECRUITING

CHU Clermont-Ferrand: Site Gabriel-Montpied

Clermont-Ferrand, France

RECRUITING

Hopital Nord, AP-HM

Marseille, France

RECRUITING

CHR Orleans, Hopital de la Source

Orléans, France

RECRUITING

Hopital Larrey, CHU du Toulouse

Toulouse, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 37117213 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.

  PMID: 36048877 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

masitinib; isoquercitrin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pascal Chanez, MD

  Department of Respiratory Diseases, Aix-Marseille University, Marseille, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Study Coordinator

CONTACT

+33(0)147200014; clinical@ab-science.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 10, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)