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Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Sponsor
AB Science (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05047783
Collaborator
(none)
78
Enrollment
6
Locations
4
Arms
12.3
Anticipated Duration (Months)
13
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Masitinib Mesylate
  • Drug: Placebo
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, Double-Blind, Placebo-ControlledRandomized, Double-Blind, Placebo-Controlled
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Anti-viral Efficacy of Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
Actual Study Start Date :
Nov 23, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Masitinib 3.0 mg/kg/day

Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care)

Drug: Masitinib Mesylate
3CL-protease inhibitor
Other Names:
  • Masitinib
  • AB1010

    		•
    Experimental: Masitinib 4.5 mg/kg/day

    Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo (all patients will receive Best Supportive Care)

    Drug: Masitinib Mesylate
    3CL-protease inhibitor
    Other Names:
  • Masitinib
  • AB1010

    		•
    Experimental: Masitinib 6.0 mg/kg/day

    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 (all patients will receive Best Supportive Care)

    Drug: Masitinib Mesylate
    3CL-protease inhibitor
    Other Names:
  • Masitinib
  • AB1010

    		•
    Placebo Comparator: Placebo

    Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. SARS-Cov-2 Viral Load at Day 10 [Baseline to Day 10]

      Time-weighted average change from baseline in viral shedding

    Secondary Outcome Measures

    1. SARS-Cov-2 Viral Load to post-baseline study days [Baseline up to Day 28]

      Time-weighted average change from baseline in viral shedding

    2. Time to negative RT-qPCR result [Baseline up to Day 28]

      Time to negative RT-qPCR result in all tested samples with no subsequent positive RT-qPCR in any tested samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Male or non-pregnant female with: A. Symptomatic ambulatory male or non-pregnant female adult ≥ 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 female adult ≥ 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 days before randomization

    • Positive test for COVID-19 ≤72 hours prior to randomization

    • Negative test for the IgG anti-SARS-CoV-2

    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) any time before participating in the study

    • Receipt of last recommended dose of a SARS-CoV-2 vaccine up to 30 days before participating 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Intensive Care Unit, CHU Gabriel-Montpied Clermont-Ferrand France
    2 Gabrichevsky Institute of Epidemiology and Microbiology Moscow Russian Federation
    3 Scientific Research Center Eco-Safety Saint Petersburg Russian Federation
    4 City Clinical Hospital No. 14 Yekaterinburg Russian Federation
    5 Netcare Jakaranda Hospital Pretoria Gauteng South Africa
    6 Langeberg Clinical Trials Cape Town Western Cape South Africa

    Sponsors and Collaborators

    • AB Science

    Investigators

    • Principal Investigator: Guillaume LAURICHESSE, MD, CHU Gabriel-Montpied, Clermont-Ferrand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AB Science
    ClinicalTrials.gov Identifier:
    NCT05047783
    Other Study ID Numbers:
    • AB21002
    • 2021-002620-20
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 23, 2022