| Trial registration number
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EUCTR2020-001333-13-FR |
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001333-13/FR
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First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Groupe Hospitalier Paris Saint Joseph - Hôpital Marie Lannelongue - Clinical research project manager
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Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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l.lamrani@hml.fr
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Registration date
Last imported at : March 14, 2023, 8 a.m.
Source : EU Clinical Trials Register
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2020-04-02
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Recruitment status
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Terminated
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Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Randomized
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Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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1. Patient aged > 18
2. Patient affiliated to a health insurance plan
3. Patient who has given their free, informed and written consent or patient for whom an independent doctor has given their signed consent as part of an emergency procedure
4. Serum Potassium> 3,5 mmol / L
5. Patient diagnosed COVID positive by RT-PCR and / or scanner
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Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
1. Patient under guardianship or curatorship
2. Patient with plausible alternate diagnosis
3. ARDS evolving for more than 4 days
4. Contraindication to the HCQ
5. Contraindication to DXM
6. Uncontrolled septic shock
7. Untreated active infection or treated less than 24 hours
8. Long-term patient treated with corticosteroids (> 20 mg / day) or HCQ
9. Immunocompromised patients: AIDS, bone marrow or solid organ transplant recipients
10. Pregnant women
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Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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2
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Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Groupe Hospitalier Paris Saint-Joseph
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Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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None
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Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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France
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Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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6: Severe disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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122
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primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Mortality on D28
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Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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nan
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Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Phase 3
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Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1552, "treatment_name": "Dexamethasone+hydroxychloroquine", "treatment_type": "Corticosteroids+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]
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