E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients atteints d’une infection SARS-CoV2 non hospitalisés |
patients atteints d’une infection SARS-CoV2 non hospitalisés |
|
E.1.1.1 | Medical condition in easily understood language |
Patients atteints d’une infection SARS-CoV2 non hospitalisés |
Patients atteints d’une infection SARS-CoV2 non hospitalisés |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10021879 |
E.1.2 | Term | Infections - pathogen unspecified |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Efficacité de l’association tenofovir/emtricitabine pendant 7 jours sur la négativation du portage nasopharyngé de SARS-CoV2 à J4 |
Efficacité de l’association tenofovir/emtricitabine pendant 7 jours sur la négativation du portage nasopharyngé de SARS-CoV2 à J4 |
|
E.2.2 | Secondary objectives of the trial |
• Réduction de la durée des symptômes • Rapidité de la décroissance virale SARS-CoV2 entre J4 et J1 • Tolérance du TDF/FTC • Proportion d’hospitalisation secondaire
|
• Réduction de la durée des symptômes • Rapidité de la décroissance virale SARS-CoV2 entre J4 et J1 • Tolérance du TDF/FTC • Proportion d’hospitalisation secondaire
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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
|
|
E.4 | Principal exclusion criteria |
- 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4 |
Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Délai de disparition des symptômes COVID • Négativation du portage nasopharyngé SARS-CoV2 par PCR à J7
|
• Délai de disparition des symptômes COVID • Négativation du portage nasopharyngé SARS-CoV2 par PCR à J7
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
prise en charge classique |
prise en charge classique |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
date de la dernière visite du dernier patient |
date de la dernière visite du dernier patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 7 |