Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Sponsor
AB Science
Study ID
NCT05047783
Phase
PHASE2
Status
Unknown

Conditions

  • Coronavirus Disease 2019
  • Covid19
  • SARS-CoV2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 23, 2021
Status verified
Feb 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib 3.0 mg/kg/day
    Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care)
  • Experimental: Masitinib 4.5 mg/kg/day
    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)
  • Experimental: Masitinib 6.0 mg/kg/day
    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)
  • Placebo Comparator: Placebo
    Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis

Primary Outcome Measure

SARS-Cov-2 Viral Load at Day 10 [ Time Frame: Baseline to Day 10 ]

Central Contacts

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