Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Last updated: February 3, 2023
Sponsor: AB Science
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Sars-cov-2

Treatment

N/A

Clinical Study ID

NCT05047783
AB21002
2021-002620-20
  • Ages > 18
  • All Genders

Study Summary

The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate COVID-19.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or non-pregnant female with: A. Symptomatic ambulatory male or non-pregnant femaleadult ≥ 18 years of age at time of enrolment with mild COVID-19 with score 2 or 3 of the 10-score WHO clinical progression scale OR B. Hospitalized male or non-pregnant femaleadult ≥ 18 years of age at time of enrolment with COVID-19 with score 4 or 5 of the 10-score WHO clinical progression scale.
  • Symptoms consistent with COVID-19, as determined by investigator, with onset ≤5 daysbefore randomization
  • Positive test for COVID-19 ≤72 hours prior to randomization
  • Negative test for the IgG anti-SARS-CoV-2

Exclusion

Key Exclusion Criteria:

  • Any use of anti-viral medications up to 7 days before participating in the study
  • Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) anytime before participating in the study
  • Receipt of last recommended dose of a SARS-CoV-2 vaccine up to 30 days beforeparticipating in the study
  • Receipt of a monoclonal antibodies up to 30 days before participating in the study. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 78
Study Start date:
November 23, 2021
Estimated Completion Date:
December 31, 2023

Study Description

The primary objective is to evaluate the virologic efficacy of masitinib plus Best Supportive Care (BSC), with respect to placebo plus BSC in reducing viral shedding of SARS-CoV-2 in patients with symptomatic mild to moderate COVID-19.

Patients will be randomized into one of the following treatment groups (all patients will receive BSC):

  1. Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo

  2. Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo

  3. Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 2 days then 6.0 mg/kg/day for 6 days versus corresponding placebo Treatments will be administered for 10 days and patients will be followed for 1 month. The treatment groups will be compared to pooled placebo after unblinding.

Regarding Best Supportive Care, for patients with a score of 2 and 3 (ambulatory) on the 10-score WHO clinical progression scale, Best Supportive Care is best available therapy in the country at the choice of the investigator excluding any antiviral treatment whether indirect (Ribavirin, Hydroxychloroquine or Chloroquine) or direct (anti-polymerase or antiprotease, including lopinavir/ritonavir fixed dose combination), other investigational treatments for SARS-CoV-2, plasma from a person who recovered from COVID-19, monoclonal antibody therapies and vaccine. For patients with a score of 4 and 5 (hospitalized) on the 10-score WHO clinical progression scale, Best Supportive Care is dexamethasone.

Connect with a study center

  • Intensive Care Unit, CHU Gabriel-Montpied

    Clermont-Ferrand,
    France

    Site Not Available

  • Gabrichevsky Institute of Epidemiology and Microbiology

    Moscow,
    Russian Federation

    Active - Recruiting

  • Scientific Research Center Eco-Safety

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • City Clinical Hospital No. 14

    Yekaterinburg,
    Russian Federation

    Active - Recruiting

  • Netcare Jakaranda Hospital

    Pretoria, Gauteng
    South Africa

    Active - Recruiting

  • Langeberg Clinical Trials

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

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