Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Coronavirus Disease 2019; SARS-CoV2 Infection
• Intervention / Treatment: Drug: Placebo; Drug: Masitinib Mesylate

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 Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Not yet recruiting
    • Intensive Care Unit, CHU Gabriel-Montpied
• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Gabrichevsky Institute of Epidemiology and Microbiology
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Scientific Research Center Eco-Safety
  • Yekaterinburg, Russian Federation
    • Recruiting
    • City Clinical Hospital No. 14
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa
      • Recruiting
      • Netcare Jakaranda Hospital
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Recruiting
      • Langeberg Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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: AB1010; Masitinib
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: AB1010; Masitinib
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: AB1010; Masitinib
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-Cov-2 Viral Load at Day 10	Time-weighted average change from baseline in viral shedding	Baseline to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-Cov-2 Viral Load to post-baseline study days	Time-weighted average change from baseline in viral shedding	Baseline up to Day 28
Time to negative RT-qPCR result	Time to negative RT-qPCR result in all tested samples with no subsequent positive RT-qPCR in any tested samples	Baseline up to Day 28

Collaborators and Investigators

• Sponsor: AB Science

Publications and helpful links

General Publications

• Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (ACTUAL): September 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AB21002; 2021-002620-20 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No