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
Brief Summary

The objective of the study is to evaluate the anti-viral efficacy of 3 different dosagesof 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.

Unknown status
COVID19
SARS-CoV2 Infection
Coronavirus Disease 2019

Drug: Masitinib Mesylate

3CL-protease inhibitor
Other Name: Masitinib,AB1010

Drug: Placebo

Placebo

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Russian Federation
South Africa
Locations

Intensive Care Unit, CHU Gabriel-Montpied
Clermont-Ferrand, France

Gabrichevsky Institute of Epidemiology and Microbiology
Moscow, Russian Federation

Scientific Research Center Eco-Safety
Saint Petersburg, Russian Federation

City Clinical Hospital No. 14
Yekaterinburg, Russian Federation

Netcare Jakaranda Hospital
Pretoria, Gauteng, South Africa

Langeberg Clinical Trials
Cape Town, Western Cape, South Africa

Contacts

Clinical Study Coordinator
+33(0)147200014
clinical@ab-science.com

Guillaume LAURICHESSE, MD, Principal Investigator
CHU Gabriel-Montpied, Clermont-Ferrand

NCT Number
MeSH Terms
COVID-19