NCT05047783

Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• SARS-CoV2 Infection
• Coronavirus Disease 2019

Interventions

Type	Name	Description
DRUG	Masitinib Mesylate	3CL-protease inhibitor
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-11-23
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-09-17
• Last updated: 2023-02-06

Locations

6 sites across 3 countries: France, Russia, South Africa

Regulatory

• FDA-regulated drug study