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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05047783
Other study ID # AB21002
Secondary ID 2021-002620-20
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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