Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL)

Coronavirus Infection Clinical Trial

— COVID-PSL  

Official title:

Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402905
• Other study ID #: CREPATS 011
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: February 2021
• Source: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
France	Yasmine Dudoit	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-PSL Cohort	measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30	3 months