Clinical trial NCT05047783: Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
SARS-CoV2 Infection
Coronavirus Disease 2019
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-Cov-2 Viral Load at Day 10
timeFrame: Baseline to Day 10
Secondary outcomes:
measure: SARS-Cov-2 Viral Load to post-baseline study days
timeFrame: Baseline up to Day 28
measure: Time to negative RT-qPCR result
timeFrame: Baseline up to Day 28
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Intensive Care Unit, CHU Gabriel-Montpied
city: Moscow
country: Russian Federation
facility: Gabrichevsky Institute of Epidemiology and Microbiology
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Center Eco-Safety
city: Yekaterinburg
country: Russian Federation
facility: City Clinical Hospital No. 14
city: Pretoria
country: South Africa
facility: Netcare Jakaranda Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: Langeberg Clinical Trials
state: Western Cape
Study officials:
affiliation: CHU Gabriel-Montpied, Clermont-Ferrand
name: Guillaume LAURICHESSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.