NCT04412031

Brief Summary

The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project" registered in ClinicalTrials (NCT04290780). In the current pandemic context, medical resources have often been exceeded. Developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. Thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of Covid-19 at the hospital admission of patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 29, 2020

Last Update Submit

June 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Need of mechanical ventilation, transfer to an intensive care unit or death within 21 days of admission.

    within 21 days

Interventions

non applicable

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project" It is an international multicentre prospective, observational, hospital-based study in adults. It will include volunteer patients, care givers and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project. A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR. Characteristics of the study participants, the proportion of confirmed nosocomial SARS-CoV2 infections relative to all patients with syndromes suggestive of 2019-nCoV infection will be analyzed.

You may qualify if:

  • Participant must be 18 years or older at the time of signing the informed consent
  • Volunteer patients, care givers and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project.
  • A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR.
  • Admission to hospital

You may not qualify if:

  • Age lower than 18 years old
  • Patients protected by the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital E Herriot - Hospices Civils de LYON

Lyon, 69437, France

Location

Study Design

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

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 2, 2020

Study Start

November 11, 2019

Primary Completion

May 14, 2020

Study Completion

May 15, 2020

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations