Covid19Phase 2NCT05047783
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
A Phase 2 study testing Masitinib Mesylate in people with Covid19 and SARS-CoV2 Infection, run by AB Science at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV2 Infection, Coronavirus Disease 2019
- What is being tested?
- Masitinib Mesylate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 23 Nov 2021to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Russia3 sites, 3 recruiting
- Recruiting
Gabrichevsky Institute of Epidemiology and Microbiology
Moscow
- Recruiting
Scientific Research Center Eco-Safety
Saint Petersburg
- Recruiting
City Clinical Hospital No. 14
Yekaterinburg
South Africa2 sites, 2 recruiting
- Recruiting
Langeberg Clinical Trials
Cape Town, Western Cape
- Recruiting
Netcare Jakaranda Hospital
Pretoria, Gauteng
France1 site, 1 recruiting
- Not yet recruiting
Intensive Care Unit, CHU Gabriel-Montpied
Clermont-Ferrand
About this study
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
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.
Read the 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):
- Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo
- Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo
- 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
- Being tested
- Masitinib Mesylate, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masitinib MesylateDrug
Also called Masitinib, AB1010
3CL-protease inhibitor
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Masitinib 3.0 mg/kg/day | Experimental | Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care) Receives: Drug: Masitinib Mesylate |
| Masitinib 4.5 mg/kg/day | Experimental | 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) Receives: Drug: Masitinib Mesylate |
| Masitinib 6.0 mg/kg/day | Experimental | 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) Receives: Drug: Masitinib Mesylate |
| Placebo | Placebo comparator | Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-Cov-2 Viral Load at Day 10
Time-weighted average change from baseline in viral shedding
Measured: Baseline to Day 10
Secondary outcomes (2)
SARS-Cov-2 Viral Load to post-baseline study days
Time-weighted average change from baseline in viral shedding
Measured: Baseline up to Day 28
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
Measured: Baseline up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start23 Nov 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillaume LAURICHESSE, MD, Principal investigator, CHU Gabriel-Montpied, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047783
- Sponsor's protocol ID
- AB21002
- Other IDs
- 2021-002620-20
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.
Publications
Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.
PubMed 36048877
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05047783
- Acronym / sponsor ID
- AB21002
- Conditions
- Covid19, SARS-CoV2 Infection, Coronavirus Disease 2019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo
- Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Masitinib 3.0 mg/kg/day | Experimental | Drug: Masitinib MesylateMasitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care) |
| Masitinib 4.5 mg/kg/day | Experimental | Drug: Masitinib MesylateMasitinib 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) |
| Masitinib 6.0 mg/kg/day | Experimental | Drug: Masitinib MesylateMasitinib 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 | Placebo comparator | Drug: PlaceboPlacebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masitinib MesylateAlso: Masitinib, AB10103CL-protease inhibitor | Drug | Masitinib 3.0 mg/kg/day, Masitinib 4.5 mg/kg/day, Masitinib 6.0 mg/kg/day |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
SARS-Cov-2 Viral Load at Day 10
Time frame: Baseline to Day 10
Time-weighted average change from baseline in viral shedding
2 secondary outcomes
SARS-Cov-2 Viral Load to post-baseline study days
Time frame: Baseline up to Day 28
Time to negative RT-qPCR result
Time frame: Baseline up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 36048877Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.
- Individual participant dataSharing planned: No. Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume LAURICHESSE, MD principal investigator
CHU Gabriel-Montpied, Clermont-Ferrand
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Masitinib Mesylate in people with Covid19 and SARS-CoV2 Infection, run by AB Science at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia, South Africa, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Coordinator (+33(0)147200014, clinical@ab-science.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-Cov-2 Viral Load at Day 10 (time frame: Baseline to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.