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 (Other)
Overall Status
Completed
CT.gov ID
NCT04402905
Collaborator
(none)
450
1
2
224.5

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.
    Actual Study Start Date :
    Jun 15, 2020
    Actual Primary Completion Date :
    Jul 15, 2020
    Actual Study Completion Date :
    Aug 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. COVID-PSL Cohort [3 months]

      measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yasmine Dudoit Paris France 75013

    Sponsors and Collaborators

    • Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

    Investigators

    • Principal Investigator: Christine Katlama, MD, Pitie-Salpetriere Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
    ClinicalTrials.gov Identifier:
    NCT04402905
    Other Study ID Numbers:
    • CREPATS 011
    First Posted:
    May 27, 2020
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2021