REassessement After Hospitalization for Sars-COV-2 disordER

NCT04443257 | Terminated

• 1 other identifier: RECHMPL20_0340
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2 infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

Conditions

Sars-CoV2

Keywords

comorbidities; Sars-CoV2; sequelae; patient outcome assessment; Covid19; quality of life

Outcome Measures

Primary Outcomes (1)

• Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry

  3 to 6 months after Sars coV 2 infection

Secondary Outcomes (18)

• Assessment of dyspnea

  3 to 6 months after Sars coV 2 infection

• Description of pulmonary lesions as assessed by lung CT scan

  3 to 6 months after Sars coV 2 infection

• Development of pulmonary fibrosis as assessed by lung CT scan

  3 to 6 months after Sars coV 2 infection

• Incidence or worsening of cardiovascular diseases

  3 to 6 months after Sars coV 2 infection

• Incidence or worsening of renal disease

  3 to 6 months after Sars coV 2 infection

Interventions

assessment of the sequelae after hospitalization for Sars-COV-2 OTHER

the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier University Hospital

You may qualify if:

• patient who was hospitalized within 3 to 6 months for a sars-CoV infection

You may not qualify if:

• Absence of signed informed consent
• pregnancy or breastfeeding
• patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Berger M, Daubin D, Charriot J, Klouche K, Le Moing V, Morquin D, Halimi L, Jaussent A, Taourel P, Hayot M, Cristol JP, Nagot N, Fesler P, Roubille C. Mid-Term Sequelae of Surviving Patients Hospitalized in Intensive Care Unit for COVID-19 Infection: The REHCOVER Study. J Clin Med. 2023 Jan 28;12(3):1000. doi: 10.3390/jcm12031000.

  PMID: 36769648 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: July 8, 2020
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)