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

Sponsor
AB Science
Study ID
NCT04622865
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Jun 1, 2020
Status verified
Feb 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib plus Isoquercetin plus 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.
  • Active Comparator: 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.

Primary Outcome Measure

Clinical status of patients at day-15 using a 7-point ordinal scale [ Time Frame: 15 days ]

Central Contacts

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