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

NCT04402905 | Completed DMC

• 1 other identifier: CREPATS 011
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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?

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• COVID-PSL Cohort

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

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patient objecting to the use of their data for research purposes
• Patient under justice or deprived of liberty.

Sponsors & Collaborators

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

Study Sites (1)

Yasmine Dudoit

Paris, 75013, France

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Christine Katlama, MD

  Pitie-Salpetriere Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: June 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: August 15, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

FR (1)