Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

NCT ID: NCT05047783

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2023-12-31

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.

Conditions

Covid19; SARS-CoV2 Infection; Coronavirus Disease 2019

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Masitinib Mesylate

Intervention Type: DRUG

3CL-protease inhibitor

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)

Group Type: EXPERIMENTAL

Masitinib Mesylate

Intervention Type: DRUG

3CL-protease inhibitor

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)

Group Type: EXPERIMENTAL

Masitinib Mesylate

Intervention Type: DRUG

3CL-protease inhibitor

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Masitinib Mesylate

3CL-protease inhibitor

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Masitinib; AB1010

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AB Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume LAURICHESSE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Gabriel-Montpied, Clermont-Ferrand

Locations

Intensive Care Unit, CHU Gabriel-Montpied

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

Gabrichevsky Institute of Epidemiology and Microbiology

Moscow, , Russia

Site Status: RECRUITING

Scientific Research Center Eco-Safety

Saint Petersburg, , Russia

Site Status: RECRUITING

City Clinical Hospital No. 14

Yekaterinburg, , Russia

Site Status: RECRUITING

Netcare Jakaranda Hospital

Pretoria, Gauteng, South Africa

Site Status: RECRUITING

Langeberg Clinical Trials

Cape Town, Western Cape, South Africa

Site Status: RECRUITING

Countries

France; Russia; South Africa

Central Contacts

Clinical Study Coordinator

Role: CONTACT

clinical@ab-science.com

+33(0)147200014

References

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.

Reference Type: DERIVED

PMID: 36048877 (View on PubMed)

Other Identifiers

2021-002620-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AB21002

Identifier Type: -

Identifier Source: org_study_id