Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

NCT05047783 | Unknown Phase 2 DMC FDA Drug

• 2 other identifiers: AB210022021-002620-20
• Study Type: interventional
• Target: 78
• Locations: 3 countries
• Sites: 6

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.

Conditions

Covid19; SARS-CoV2 Infection; Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (1)

• SARS-Cov-2 Viral Load at Day 10

  Time-weighted average change from baseline in viral shedding

  Baseline to Day 10

Secondary Outcomes (2)

• SARS-Cov-2 Viral Load to post-baseline study days

  Baseline up to Day 28

• Time to negative RT-qPCR result

  Baseline up to Day 28

Study Arms (4)

Masitinib 3.0 mg/kg/day

EXPERIMENTAL

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

Drug: Masitinib Mesylate

Masitinib 4.5 mg/kg/day

EXPERIMENTAL

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

Masitinib 6.0 mg/kg/day

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Masitinib Mesylate DRUG

3CL-protease inhibitor

Also known as: Masitinib, AB1010

Masitinib 3.0 mg/kg/day; Masitinib 4.5 mg/kg/day; Masitinib 6.0 mg/kg/day

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AB Science: lead

Study Sites (6)

Intensive Care Unit, CHU Gabriel-Montpied

Clermont-Ferrand, France

NOT YET RECRUITING

Gabrichevsky Institute of Epidemiology and Microbiology

Moscow, Russia

RECRUITING

Scientific Research Center Eco-Safety

Saint Petersburg, Russia

RECRUITING

City Clinical Hospital No. 14

Yekaterinburg, Russia

RECRUITING

Netcare Jakaranda Hospital

Pretoria, Gauteng, South Africa

RECRUITING

Langeberg Clinical Trials

Cape Town, Western Cape, South Africa

RECRUITING

Related Publications (1)

• 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.

  PMID: 36048877 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

masitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guillaume LAURICHESSE, MD

  CHU Gabriel-Montpied, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Study Coordinator

CONTACT

+33(0)147200014; clinical@ab-science.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 17, 2021
• Study Start: November 23, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ZA (2); RU (3)