Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047783
• Other study ID #: AB21002
• Secondary ID: 2021-002620-20
• Status: Recruiting
• Phase: Phase 2
• Start date: November 23, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: AB Science
• Contact: Clinical Study Coordinator
• Phone: +33(0)147200014
• Email: clinical[@]ab-science.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• COVID-19
• Covid19
• SARS-CoV2 Infection

Intervention

Drug:
• Masitinib Mesylate
3CL-protease inhibitor
• Placebo
Placebo

Locations

Country	Name	City	State
France	Intensive Care Unit, CHU Gabriel-Montpied	Clermont-Ferrand
Russian Federation	Gabrichevsky Institute of Epidemiology and Microbiology	Moscow
Russian Federation	Scientific Research Center Eco-Safety	Saint Petersburg
Russian Federation	City Clinical Hospital No. 14	Yekaterinburg
South Africa	Langeberg Clinical Trials	Cape Town	Western Cape
South Africa	Netcare Jakaranda Hospital	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

France,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-Cov-2 Viral Load at Day 10	Time-weighted average change from baseline in viral shedding	Baseline to Day 10
Secondary	SARS-Cov-2 Viral Load to post-baseline study days	Time-weighted average change from baseline in viral shedding	Baseline up to Day 28
Secondary	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	Baseline up to Day 28