NCT04681755

Brief Summary

Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/). Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 19, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 21, 2020

Last Update Submit

December 23, 2020

Conditions

Keywords

RehabilitationSARS-CoV-2COVID-19Neurological functionRespiratory disorderIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • Retrospective analysis of the neurological disorder after severe SARS-CoV-2 infection

    The files analysed retrospectily from February 24, 2020 to April 15, 2020 will be examined]

Eligibility Criteria

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

Adult patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.

You may qualify if:

  • Adult patient (≥18 years old)
  • Patient hospitalized in surgical intensive care at the New Civil Hospital between February 24 and April 15, 2020.
  • Patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
  • Patient who has given his consent for the use of his data for the purposes of this research

You may not qualify if:

  • Patient without documentation of SARS-CoV-2 infection (RT-PCR or chest scanner)
  • Patient who expressed his opposition to participating in the study
  • Subject under safeguard of justice
  • Subject under guardianship or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strasbourg University Hospitals - Anesthesia and surgical resuscitation service

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19Respiration Disorders

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 23, 2020

Study Start

May 19, 2020

Primary Completion

May 19, 2021

Study Completion

May 19, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12

Locations