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Trial - EUCTR2020-001867-94-FR


Column Value
Trial registration number EUCTR2020-001867-94-FR
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

CHU CAEN Normandie - Investigateur Coordinateur

Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

parienti-jj@chu-caen.fr

Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2020-04-20

Recruitment status
Last imported at : March 1, 2022, 8:58 p.m.
Source : EU Clinical Trials Register

Terminated

Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

- 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

Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

- 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

Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

CHU CAEN Normandie

Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

France

Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

180

primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4 Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4

Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

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

Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Phase 3

Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

[{"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"}]