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.
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.
Drug: Masitinib Mesylate
3CL-protease inhibitor
Other Name: Masitinib,AB1010
Drug: Placebo
Placebo
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
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
Clinical Study Coordinator
+33(0)147200014
clinical@ab-science.com
Guillaume LAURICHESSE, MD, Principal Investigator
CHU Gabriel-Montpied, Clermont-Ferrand