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| Column | Value |
|---|---|
| Trial registration number | NCT04685512 |
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Full text link
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
François Fournel, fournel-f@chu-caen.fr (PI email not reported) |
|
Registration date
Last imported at : Dec. 31, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-12-28 |
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Recruitment status
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - patients 18 years and over - sars-cov2 infection confirmed by pcr - patients who do not require immediate hospitalization - signed informed consent non-inclusion criteria: - patients with hiv or hepatitis b - symptoms suggestive of a sars-cov2 infection that has been progressing for more than 7 days - asympomatic patients with unknown date of infection or date of infection>7 days - chronic hcv infection - contraindication to the use of tdf/ftc - hypersensitivity to tenofovir, to emtricitabine or to any of the excipients (especially lactose) - glomerular filtration rate <80ml / min - recent (less than 7 days) or concomitant use of nsaids or other nephrotoxic drugs (antiinfectives, immunosuppressants, allopurinol, lithium - need for hospitalization for contemporary decompensation of a comorbidity - need for hospitalization due to sars-cov2 infection: - capillary oximetry less than 95% - clinical evaluation by the investigating doctor leading to hospitalization - pregnant or breastfeeding women |
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Exclusion criteria
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
- diagnosis of pregnancy during treatment |
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Number of arms
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
University Hospital, Caen |
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Inclusion age min
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
60 |
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primary outcome
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 2B: Reduction of SARS-CoV2 viral load assessed by Ct PCR at day-4 adjusted on Ct PCR SARS-CoV2 viral load at baseline (ANCOVA);Phase 3: Rate of non-contagious nasopharyngeal sample for SARS-CoV2 by PCR on Day-4 with Ct > or = 28 |
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Notes
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"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"}] |