A Phase 2 interventional study of Masitinib Mesylate and Placebo in Covid19, SARS-CoV2 Infection and Coronavirus Disease 2019, sponsored by AB Science. Status unknown at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by AB Science · Phase 2, Interventional, and Treatment
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.
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):
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 78 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →AB Science is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care)
Drug: 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)
Drug: 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)
Drug: Masitinib Mesylate
Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis
Drug: Placebo
3CL-protease inhibitor
Also known as: Masitinib, AB1010
Placebo
SARS-Cov-2 Viral Load at Day 10
Time-weighted average change from baseline in viral shedding
Time frame: Baseline to Day 10
SARS-Cov-2 Viral Load to post-baseline study days
Time-weighted average change from baseline in viral shedding
Time frame: Baseline up to Day 28
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
Time frame: Baseline up to Day 28
Plan to share: No — Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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