Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-04 @ 6:33 PM
Study NCT ID:
NCT04402905
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL)
Sponsor:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Organization:
Study Overview
Official Title:
Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-PSL
Brief Summary:
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?
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?
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: