Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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): Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo 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.

Official Title
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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

Conditions
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Covid19, SARS-CoV2 Infection, Coronavirus Disease 2019

Intervention / Treatment
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* Drug: Masitinib Mesylate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masitinib 3.0 mg/kg/day<br>Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care) | Drug: Masitinib Mesylate<br>* 3CL-protease inhibitor<br>* Other names: AB1010;|
| Experimental: Masitinib 4.5 mg/kg/day<br>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<br>* 3CL-protease inhibitor<br>* Other names: AB1010;|
| Experimental: Masitinib 6.0 mg/kg/day<br>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<br>* 3CL-protease inhibitor<br>* Other names: AB1010;|
| Placebo Comparator: Placebo<br>Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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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 |