COVID-19: Respiratory and Sleep Follow-up

NCT04406324 | Active Not Recruiting DMC

• 1 other identifier: 38RC20.157
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 4

Brief Summary

The current project is a prospective, multicentric cohort study aiming at a multidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of the consequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to better characterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2 will be included in the study 3 months after their diagnosis: They will be followed at 6 months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3 months and their evolution.

Conditions

COVID-19

Keywords

COVID-19; Pulmonary function; Sleep disorders; Post-traumatic stress; Cardiac function; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis

  Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO)

  3 months after COVID diagnosis

Secondary Outcomes (10)

• Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis

  3 months after COVID diagnosis

• Prevalence of sleep disorders 3 months after COVID diagnosis

  3 months after COVID diagnosis

• Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis

  3 months after COVID diagnosis

• Prevalence of cardiac impairments 3 months after COVID diagnosis

  3 months after COVID diagnosis

• Follow-up of pulmonary diffusion capacity of carbon monoxide

  From Baseline (3 months after COVID diagnosis) to 5 years

Study Arms (1)

SARS-CoV-2 patients

Patients infected by SARS-CoV-2

Other: No intervention

Interventions

No intervention OTHER

No Intervention. The study consists in a prospective clinical longitudinal follow-up

SARS-CoV-2 patients

Eligibility Criteria

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

Study Population

Patients infected by SARS-CoV-2

You may qualify if:

• Male or Female, aged \> 18 years
• With a positive diagnosis for SARS-COVID-19, confirmed by RT-PCR or with compatible symptoms
• Signed informed consent by patient
• Affiliated to a French social and health insurance system or equivalent
• For biological collection: patient eligible for sampling (weight \>50kg and hemoglobin \>7g/dL) and signed inform consent for collection

You may not qualify if:

• Pregnant or breastfeeding women
• Prisoners or patients who require protection by the law
• Patients not affiliated to a French social and health insurance system or equivalent
• Ages \<18 years
• Diagnosis of infection by other pathogen than SARS-COVID-19 or no indication of infection by COVID-19

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (4)

Hôpital Avicenne

Bobigny, 93000, France

Location

Centre Hospitalier Henri Mondor, APHP

Créteil, 94000, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

CHRU Nancy

Nancy, 54000, France

Location

Related Publications (5)

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9. doi: 10.1136/thx.2004.030205.

  PMID: 15860716 BACKGROUND

• Burnham EL, Hyzy RC, Paine R 3rd, Coley C 2nd, Kelly AM, Quint LE, Lynch D, Janssen WJ, Moss M, Standiford TJ. Chest CT features are associated with poorer quality of life in acute lung injury survivors. Crit Care Med. 2013 Feb;41(2):445-56. doi: 10.1097/CCM.0b013e31826a5062.

  PMID: 23263616 BACKGROUND

• Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.

  PMID: 27025938 BACKGROUND

• Luyt CE, Combes A, Becquemin MH, Beigelman-Aubry C, Hatem S, Brun AL, Zraik N, Carrat F, Grenier PA, Richard JM, Mercat A, Brochard L, Brun-Buisson C, Chastre J; REVA Study Group. Long-term outcomes of pandemic 2009 influenza A(H1N1)-associated severe ARDS. Chest. 2012 Sep;142(3):583-592. doi: 10.1378/chest.11-2196.

  PMID: 22948576 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine

MeSH Terms

Conditions

COVID-19; Sleep Wake Disorders; Sleep Apnea Syndromes

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; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Renaud Tamisier, MD, PhD, MBA

  University Hospital Grenoble Aples

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 28, 2020
• Study Start: June 6, 2020
• Primary Completion: March 7, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

FR (4)