Trial registration number
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EUCTR2020-001867-94-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/2020-001867-94/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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CHU CAEN Normandie - Investigateur Coordinateur
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Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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parienti-jj@chu-caen.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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2020-04-20
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Recruitment status
Last imported at : March 1, 2022, 8:58 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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single-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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- Infection confirmée par le SARS-CoV2
- Patients ne nécessitant pas l’hospitalisation
- Consentement éclairé signé
- Infection confirmée par le SARS-CoV2
- Patients ne nécessitant pas l’hospitalisation
- Consentement éclairé signé
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Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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- Patients porteur du VIH ou de l’Hépatite B
- Contre-indication à l’utilisation du TDF/FTC
- Insuffisance rénale sévère connue
- Femmes enceintes ou allaitantes
- Patients porteur du VIH ou de l’Hépatite B
- Contre-indication à l’utilisation du TDF/FTC
- Insuffisance rénale sévère connue
- Femmes enceintes ou allaitantes
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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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CHU CAEN Normandie
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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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100
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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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Mild/moderate 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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2: Mild/moderate 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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180
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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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Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4
Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4
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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 (2.0)
differs from found arms (1.0)
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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
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[{"arm_notes": "", "treatment_id": 1496, "treatment_name": "Emtricitabine+tenofovir", "treatment_type": "Antivirals", "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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