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

AB Science

Status and phase: Enrolling; Phase 2

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04622865

AB20001

2020-001635-27 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

Masitinib plus Isoquercetin plus Best Supportive Care

Experimental group

Description:

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.

Treatment:

Drug: Isoquercetin

Drug: Best Supportive Care

Drug: Masitinib

Best Supportive Care

Active Comparator group

Description:

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.

Treatment:

Drug: Best Supportive Care