Covid19 Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Intensive Care Unit, CHU Gabriel-Montpied | Clermont-Ferrand | |
Russian Federation | Gabrichevsky Institute of Epidemiology and Microbiology | Moscow | |
Russian Federation | Scientific Research Center Eco-Safety | Saint Petersburg | |
Russian Federation | City Clinical Hospital No. 14 | Yekaterinburg | |
South Africa | Langeberg Clinical Trials | Cape Town | Western Cape |
South Africa | Netcare Jakaranda Hospital | Pretoria | Gauteng |
Lead Sponsor | Collaborator |
---|---|
AB Science |
France, Russian Federation, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SARS-Cov-2 Viral Load at Day 10 | Time-weighted average change from baseline in viral shedding | Baseline to Day 10 | |
Secondary | SARS-Cov-2 Viral Load to post-baseline study days | Time-weighted average change from baseline in viral shedding | Baseline up to Day 28 | |
Secondary | Time to negative RT-qPCR result | Time to negative RT-qPCR result in all tested samples with no subsequent positive RT-qPCR in any tested samples | Baseline up to Day 28 |
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