| Trial registration number
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NCT04325633 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04325633
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First author
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Frédéric ADNET
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Contact
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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frederic.adnet@aphp.fr
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-03-27
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Recruitment status
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Terminated
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- 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, 11:31 p.m.
Source : ClinicalTrials.gov
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- presence of do-not-resuscitate order
- pregnancy
- prisoners
- known naproxen allergy or intolerance
- severe renal failure
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Assistance Publique - Hôpitaux de Paris
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Countries
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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France
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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30
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Mortality all causes at day30
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1642, "treatment_name": "Lansoprazole+naproxen", "treatment_type": "Others pharmacological treatment+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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