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

Covid19 Clinical Trial

— REHABCOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681755
• Other study ID #: 7725
• Status: Recruiting
• Start date: May 19, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Strasbourg, France
• Contact: Walid Oulehri, MD
• Phone: 33 3 69 55 12 71
• Email: walid.oulehri[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Locations

Country	Name	City	State
France	Strasbourg University Hospitals - Anesthesia and surgical resuscitation service	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]