Coronavirus Disease 2019, Covid19, SARS-CoV2 Infection
Conditions
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.
Interventions
DRUGMasitinib Mesylate
3CL-protease inhibitor
DRUGPlacebo
Placebo
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, Double-Blind, Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-Cov-2 Viral Load at Day 10 | Baseline to Day 10 | Time-weighted average change from baseline in viral shedding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France, Russia, South Africa
Contacts
Primary ContactClinical Study Coordinator
Outcome results
None listed