NCT04365530

Brief Summary

The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (\> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data. Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization. In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,767

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

April 26, 2020

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical consequences of a Covid-19 infection in the care population

    This outcome measures the clinical consequences of a Covid-19 infection in the care population.

    Year 2

Secondary Outcomes (6)

  • Risk factors at M6

    Month 6

  • Risk factors at year 1

    Year 1

  • Risk factors at year 2

    Year 2

  • Impact of hospital reorganization on medical care at M6

    Month 6

  • Impact of hospital reorganization on medical care at Year 1

    Year 1

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patientwith symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.

You may qualify if:

  • \- Patient (of all ages) with symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.

You may not qualify if:

  • Asymptomatic patient
  • Patient objecting to the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

AURA Paris Plaisance

Paris, 75014, France

Location

Fondation Sainte-Marie

Paris, 75014, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Hôpital Bellan

Paris, 75014, France

Location

Study Officials

  • Benoit PILMIS, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2020

First Posted

April 28, 2020

Study Start

April 1, 2020

Primary Completion

June 30, 2022

Study Completion

March 6, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations