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

Phase 2

Recruiting

• Conditions: COVID-19; Coronavirus Disease 2019; SARS-CoV 2
• Interventions: Drug: Masitinib; Drug: Isoquercetin; Drug: Best Supportive Care

• Registration Number: NCT04622865
• Lead Sponsor: AB Science

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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Masitinib plus Isoquercetin plus Best Supportive Care	Best Supportive Care	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.
Best Supportive Care	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.
Masitinib plus Isoquercetin plus Best Supportive Care	Masitinib	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.
Masitinib plus Isoquercetin plus Best Supportive Care	Isoquercetin	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.

Primary Outcome Measures

Name	Time	Method
Clinical status of patients at day-15 using a 7-point ordinal scale	15 days	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.

Trial Locations

Locations (6)

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CHU Clermont-Ferrand: Site Gabriel-Montpied; 🇫🇷 Clermont-Ferrand, France

Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHR Orleans, Hopital de la Source; 🇫🇷 Orléans, France

Hopital Nord, AP-HM; 🇫🇷 Marseille, France

Hopital Larrey, CHU du Toulouse; 🇫🇷 Toulouse, France