E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infection SARS-CoV-2 |
Infection SARS-CoV-2 |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 |
Demonstrate that early treatment of COVID-19 patients with azithromycin reduces the duration of symptoms |
Montrer qu’un traitement précoce par azithromycine des patients COVID-19 permet de diminuer la durée des symptômes |
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E.2.2 | Secondary objectives of the trial |
To show that early treatment of COVID-19 patients with azithromycin allows :
-A decrease in the number of hospitalizations (especially for patients with risk factors)
-Accelerated return to work
-Decrease in the duration of symptoms
-Ancillary study: reduction of contagiousness |
Montrer qu’un traitement précoce par azithromycine des patients COVID-19 permet :
-Une diminution du nombre d’hospitalisation (en particulier pour les patients présentant des facteurs de risques)
-Une reprise accélérée du travail
-Diminution de la durée des symptômes
-Etude ancillaire : diminution de la contagiosité
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patient under care at the CHU Amiens-Picardie,
- Age ≥18 years old
- Presenting symptoms of COVID-19 with positive RT-PCR
Symptoms may include, but are not limited to: association of cough (febrile or not), myalgia, aches and pains. The occurrence of diarrhoea or anosmia/agueusia in the context are strongly suggestive. The presence of clinical pneumonia and radiological interstitial syndrome are characteristic in the context. The absence of an obvious differential diagnosis is critical.
- Non-severe patient, i.e., non-hospitalized, non-oxygen-dependent outpatient
- Having signed a consent for their participation in the study, after oral and written information |
- Patient adulte pris en charge au CHU Amiens-Picardie,
- Age ≥18 ans
- Présentant des symptômes de COVID-19 avec RT-PCR positive
Les symptômes évocateurs sont les suivants, sans être exhaustifs : association de toux (fébrile ou non), myalgies, courbatures. La survenue de diarrhée ou d’anosmie/agueusie dans le contexte sont fortement évocateurs. La présence d’une pneumonie clinique et d’un syndrome interstitielle radiologique sont caractéristiques dans le contexte. L’absence de diagnostic différentiel évident est capitale.
- Patient non grave, i.e. ambulatoire non hospitalisé, non oxygéno-dépendant
- Ayant signé un consentement pour leur participation à l’étude, après information orale et écrite
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E.4 | Principal exclusion criteria |
Related to the molecule under study:
- Patient with a contraindication to azithromycin, namely:
o Allergy to macrolides,
o Severe liver failure,
o In combination with drugs containing cisapride, colchicine, ergotamine or dihydroergotamine.
- Pregnant, parturient or breastfeeding women.
In relation to the primary endpoint :
- Asymptomatic patient
In connection with the regulation of therapeutic trials:
- Patient unable to comply with the study protocol.
- Patient under guardianship or curatorship, under protection of justice or private public law. |
En lien avec la molécule à l’étude :
- Patient présentant une contre-indication à la prise d’azithromycine, à savoir :
o Allergie aux macrolides,
o Insuffisance hépatique grave,
o En association avec des médicaments contenant du cisapride, de la colchicine, de l'ergotamine ou de la dihydroergotamine.
- Femmes enceintes, parturientes ou en cours d’allaitement.
En lien avec le critère de jugement principal :
- Patient asymptomatique
En lien avec la règlementation des essais thérapeutiques :
- Patient dans l’incapacité d’être compliant avec le protocole de l’étude
- Patient sous tutelle ou curatelle, sous sauvegarde de justice ou privée droit public. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Comparison between the 2 groups of the rate of subjects still symptomatic at D10 after initiation of treatment. |
- comparaison entre les 2 groupes du taux de sujets encore symptomatique à J10 après instauration du traitement |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
a. Comparison of Hospitalization Rate
b. Comparison of the date of resumption of professional activities
c. Comparison of total symptom duration
Ancillary study :
d. Decrease in viral load between J0 and J5
e. Neutralizing antibody level at D10 |
a. Comparaison du Taux d’hospitalisation
b. Comparaison de la date de reprise des activités professionnelles
c. Comparaison de la durée totale des symptômes
Etude ancillaire :
d. Décroissance de la charge virale entre J0 et J5
e. Taux d’anticorps neutralisants à J10
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |