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Trial - EUCTR2020-001251-41-FR


Column Value
Trial registration number EUCTR2020-001251-41-FR
Full text link
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001251-41/FR

First author
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Ch de Versailles - Morisset laure

Contact
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

lmorisset@ch-versailles.fr

Registration date
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2020-03-25

Recruitment status
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Terminated

Study design
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

multi-center

Study aim
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Prevention of SARS-Cov 2 infection. EHPAD (nursing home) will be selected for the study in case of the diagnosis of at least one resident with a documented SRAS-Cov 2 infection or a suspected COVID-19 (Fever ≥ 38°C and/or cough, thoracic pain or dyspnea) within the last 14 days. 1.Resident living is an open nurse home 2.Resident without symptom of COVID-19 3.No imatinib contra-indication 4.Signed informed consent Prevention of severe COVID-19 1.Patient aged > 70y 2.Patient with a documented SRAS-Cov 2 infection (if no test is available, suspected SARS-Cov 2 infection). 3.Initial phase (7 days) of COVID-19 4.Signed informed consent

Exclusion criteria
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

1.Patient in palliative care 2.Contra-indication to imatinib

Number of arms
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

4

Funding
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

CH de Versailles

Inclusion age min
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

65

Inclusion age max
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

France

Type of patients
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Mild/moderate disease at enrollment

Severity scale
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

382

primary outcome
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Prevention of SARS-CoV-2 infection. To evaluate the benefit of imatinib mesylate to prevent the SRAS-Cov 2 contamination in nursing home residents. Prevention of severe COVID-19 disease. To evaluate the benefit of early imatinib to prevent severe COVID-19 disease in hospitalized aged patients.

Notes
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Declared number of arm (2.0) differs from found arms (1.0)

Phase
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : Feb. 12, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]