Rehabilitation Required Due to Clinical Disorders After Severe Covid-19 Infection (REHABCOV)

Rehabilitation Required Due to Functional Neurological Impairment and Respiratory Disorders After Severe SARS-CoV-2 Infection in ICU Units

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.

Study Overview

• Status: Unknown
• Conditions: Covid19

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

• Study Contact: Name: Walid OULEHRI, MD; Phone Number: 33 3 69 55 12 71; Email: walid.oulehri@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Strasbourg University Hospitals - Anesthesia and surgical resuscitation service
    • Sub-Investigator: François SEVERAC, MD
    • Principal Investigator: Walid OULEHRI, MD
    • Contact: Walid Oulehri, MD; Phone Number: 33 3 69 55 12 72; Email: walid.oulehri@chru-strasbourg.fr
    • Sub-Investigator: Charlotte POUSSARDIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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]

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2020
• Primary Completion (Anticipated): May 19, 2021
• Study Completion (Anticipated): May 19, 2021

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; SARS-CoV-2; COVID-19; Intensive care unit; Neurological function; Respiratory disorder
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 7725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No