Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL) (COVID-PSL)
Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.
COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.
If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).
However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.
Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.
Given the novelty of this infection, several questions remain:
- What are all the symptoms that can be contracted by a COVID-19 patient?
- Are there clinical forms not described?
- What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?
- What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Most of the descriptive studies relating to COVID-19 relate to the severe forms of the disease managed in the hospital sector.
Few data have been published on moderate forms, requiring no hospitalization, of strict outpatient management.
These so-called moderate forms, however, constitute the majority of cases of COVID-19 (approximately 80%).
In the Infectious and Tropical Diseases Department of Pitie Salpetriere, COVIDOM pilot site, at the beginning of March, during the intensification of the epidemic in France, a weekly telephone consultation was set up to take care of people tested for COVID + by PCR, or people not tested by PCR, or even tested with negative PCR but symptomatic and followed at home, suffering from moderate form of COVID-19, as well as their contact cases if they wished.
Telemedicine is particularly suitable in this epidemic context, ensuring continuity of care, while limiting face-to-face consultations, thus reducing the risk of cross-contamination.
Given the novelty of this infection, it is important to be able to best characterize these ambulatory forms, as well as their evolution, in order to manage these patients, and to offer primary care physicians a more detailed description of these forms. , which they are and will be called upon to take care of, general medicine being central to dealing with the epidemic.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Paris, France, 75013
- Yasmine Dudoit
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Enrolment will be done from the active queue of patients included in the COVIDOM / PSL platform.
This study will be a monocentric data collection. The patient is called, on working days, weekly from D0 to D30, and beyond if the symptoms persist on D30.
Data will be collected at D0, D7, D14, D21 and D30. The visit on D30 corresponds to the end of the systematic weekly telephone interviews if the patient has reached complete recovery, defined by the absence of symptoms for 3 days.
If the symptoms persist on D30: monitoring is continued, on D45 and D60, and beyond if necessary.
La description
Inclusion Criteria:
- Age >18 years
- COVID PCR + patient: Patient screened positive by PCR on nasopharyngeal swab
- or COVID-like patient: Patient not screened, but considered COVID + because contact with a COVID PCR + person, and presenting symptoms suggestive of COVID-19 among:
- Influenza-like illness (fever, body aches, arthralgia, etc.)
- Respiratory form: dyspnea, cough, rhinitis
- Gastrointestinal form: diarrhea, nausea, vomiting
- Anosmia and / or ageusia
- or patient COVID PCR-: If patient tested negative by PCR on nasopharyngeal swab, but showing signs suggestive of COVID-19.
Exclusion Criteria:
- Patient objecting to the use of their data for research purposes
- Patient under justice or deprived of liberty.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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COVID-PSL Cohort
Délai: 3 months
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measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30
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3 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Christine Katlama, MD, Pitié-Salpêtrière Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CREPATS 011
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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