NCT05047783

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 2 Last updated 3 February 2023

What this trial tests

Phase 2 trial testing Masitinib Mesylate in Covid19 in 78 participants. Status unknown.

Timeline

23 November 2021

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	AB Science
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	78
Start date	23 November 2021
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	6 locations across France, Russia, South Africa

Drugs / interventions tested

• Masitinib Mesylate — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →
• SARS-CoV2 Infection — all drugs for SARS-CoV2 Infection →
• Coronavirus Disease 2019 — all drugs for Coronavirus Disease 2019 →

Sponsor

AB Science — full company profile →

Who can join

18 and older, any sex, with Covid19 or SARS-CoV2 Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• SARS-Cov-2 Viral Load at Day 10
  Time frame: Baseline to Day 10
  Time-weighted average change from baseline in viral shedding

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Structure and function of SARS-CoV and SARS-CoV-2 main proteases and their inhibition: A comprehensive review.
   Li X, Song Y. · · 2023 · cited 57× · PMID 37659195 · DOI 10.1016/j.ejmech.2023.115772
2. The research progress of SARS-CoV-2 main protease inhibitors from 2020 to 2022.
   Pang X, Xu W, Liu Y, Li H, et al · · 2023 · cited 51× · PMID 37244162 · DOI 10.1016/j.ejmech.2023.115491
3. COVID-19 metabolism: Mechanisms and therapeutic targets.
   Wang T, Cao Y, Zhang H, Wang Z, et al · · 2022 · cited 33× · PMID 35958432 · DOI 10.1002/mco2.157
4. Learning through a Pandemic: The Current State of Knowledge on COVID-19 and Cancer.
   Elkrief A, Wu JT, Jani C, Enriquez KT, et al · · 2022 · cited 33× · PMID 34893494 · DOI 10.1158/2159-8290.cd-21-1368
5. On the origins of SARS-CoV-2 main protease inhibitors.
   Janin YL. · · 2024 · cited 22× · PMID 38283212 · DOI 10.1039/d3md00493g
6. Antiviral therapy for COVID-19: Derivation of optimal strategy based on past antiviral and favipiravir experiences.
   Shiraki K, Sato N, Sakai K, Matsumoto S, et al · · 2022 · cited 20× · PMID 35121001 · DOI 10.1016/j.pharmthera.2022.108121
7. The IDentif.AI-x pandemic readiness platform: Rapid prioritization of optimized COVID-19 combination therapy regimens.
   Blasiak A, Truong ATL, Remus A, Hooi L, et al · · 2022 · cited 17× · PMID 35773329 · DOI 10.1038/s41746-022-00627-4
8. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib.
   Latham BD, Oskin DS, Crouch RD, Vergne MJ, et al · · 2022 · cited 13× · PMID 36048877 · DOI 10.1021/acs.chemrestox.2c00057