Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Phase 2

Recruiting

• Conditions: Covid19; SARS-CoV2 Infection; Coronavirus Disease 2019
• Interventions: Drug: Masitinib Mesylate; Drug: Placebo

• Registration Number: NCT05047783
• Lead Sponsor: AB Science

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.

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-17
• Study Start: 2021-11-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Masitinib 4.5 mg/kg/day	Masitinib Mesylate	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)
Masitinib 6.0 mg/kg/day	Masitinib Mesylate	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)
Placebo	Placebo	Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis
Masitinib 3.0 mg/kg/day	Masitinib Mesylate	Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care)

Primary Outcome Measures

Name	Time	Method
SARS-Cov-2 Viral Load at Day 10	Baseline to Day 10	Time-weighted average change from baseline in viral shedding

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Langeberg Clinical Trials; 🇿🇦 Cape Town, Western Cape, South Africa

Scientific Research Center Eco-Safety; 🇷🇺 Saint Petersburg, Russian Federation

Intensive Care Unit, CHU Gabriel-Montpied; 🇫🇷 Clermont-Ferrand, France

City Clinical Hospital No. 14; 🇷🇺 Yekaterinburg, Russian Federation

Gabrichevsky Institute of Epidemiology and Microbiology; 🇷🇺 Moscow, Russian Federation

Netcare Jakaranda Hospital; 🇿🇦 Pretoria, Gauteng, South Africa