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Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

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ClinicalTrials.gov Identifier: NCT04622865
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief Summary:
Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.

Condition or disease Intervention/treatment Phase
SARS-CoV 2 COVID-19 Coronavirus Disease 2019 Drug: Masitinib Drug: Isoquercetin Drug: Best Supportive Care Phase 2

Detailed Description:

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) that is associated with substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19.

Many patients with moderate and severe COVID-19, develop a "cytokine storm" that leads to severe pulmonary inflammation and various thrombotic events associated with acute respiratory distress syndrome (ARDS) and potentially death. The combination of masitinib and isoquercetin may prevent the development of these two complications. Masitinib is a potent blocker of mast cells and macrophages that are contributors to the cytokine storm. Isoquercetin inhibits disulfide isomerase (PDI), an enzyme directly involved in the formation of clots, and also decreases D-Dimer, a predictor of COVID-19 thrombosis severity.

The primary objective of this study is to evaluate efficacy of the masitinib and isoquercetin combination in moderate and severe COVID-19 patients. The primary endpoint is subject clinical status at day 15, using a 7-point ordinal scale that is defined as follows: 1. Not hospitalized, no limitations on activities; 2.Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib Combined With Isoquercetin, and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Masitinib plus Isoquercetin plus Best Supportive Care

Patients will receive oral masitinib dose of 3 mg/kg/day for 4 days then 4.5 mg/kg/day.

The dose of isoquercetin will be 1 g/day by oral route. Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs, or biologics drugs.

Drug: Masitinib
Masitinib is a small molecule drug that selectively inhibits specific tyrosine kinases such as colony-stimulating factor 1 receptor (CSF1R), c-Kit, LYN, FYN, and platelet-derived growth factor receptor (PDGFR) α and β, in the submicromolar range.
Other Name: AB1010

Drug: Isoquercetin
Isoquercetin is a flavonoid, derivative of quercetin. Isoquercetin is rapidly hydrolyzed to quercetin.
Other Names:
  • quercetin-3-O-glucoside
  • isotrifoliin

Drug: Best Supportive Care
Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs or biologics drugs.
Other Name: BSC

Active Comparator: Best Supportive Care
Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs, or biologics drugs.
Drug: Best Supportive Care
Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs or biologics drugs.
Other Name: BSC




Primary Outcome Measures :
  1. Clinical status of patients at day-15 using a 7-point ordinal scale [ Time Frame: 15 days ]
    Ordinal scale defined as follows: 1. Not hospitalized, no limitations on activities; 2.Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has laboratory-confirmed SARS-CoV-2 infection
  • Hospitalized patients for the treatment of COVID pneumopathy
  • Patients not requiring ICU at admission with moderate and severe pneumopathy according to the OMS Criteria of severity of COVID pneumopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622865


Contacts
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Contact: Clinical Study Coordinator +33(0)147200014 clinical@ab-science.com

Locations
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France
Centre Hospitalier du Pays d'Aix Recruiting
Aix-en-Provence, France
Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux Recruiting
Bordeaux, France
CHU Clermont-Ferrand: Site Gabriel-Montpied Recruiting
Clermont-Ferrand, France
Hopital Nord, AP-HM Recruiting
Marseille, France
CHR Orleans, Hopital de la Source Recruiting
Orléans, France
Hopital Larrey, CHU du Toulouse Recruiting
Toulouse, France
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Pascal Chanez, MD Department of Respiratory Diseases, Aix-Marseille University, Marseille, France
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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT04622865    
Other Study ID Numbers: AB20001
2020-001635-27 ( EudraCT Number )
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs