Overview
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-06-01
2022-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AB Science
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