| Trial registration number
|
EUCTR2020-001301-23-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/2020-001301-23/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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Assistance Publique - Hôpitaux de Paris - Eldoie SOLER
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Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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elodie.soler@aphp.fr
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Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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2020-03-26
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Recruitment status
Last imported at : Feb. 28, 2022, 8:29 p.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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COVID-19 infected patient
Age 18 years or older
Presence of pneumonia
PaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to supplementary oxygen administration in order to maintain SpO2 range in [94-98%] or lung infiltrates > 50%
Medical insurance
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Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Presence of do-not-resuscitate order
Pregnancy
Prisoners
Naproxen allergy or intolerance
Severe renal failure
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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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Assistance Publique - Hôpitaux de Paris
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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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Moderate/severe/critical 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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5: Moderate/severe/critical 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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584
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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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30-day mortality all causes
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Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Declared number of arm (3.0)
differs from found arms (2.0)
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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
|
[{"arm_notes": "", "treatment_id": 860, "treatment_name": "Naproxen", "treatment_type": "Non-steroidal anti-inflammatory", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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