- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04406324
COVID-19: Respiratory and Sleep Follow-up (Co-SURVIVORS)
COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress
Descripción general del estudio
Descripción detallada
Europe and in particular Italy, Spain and France are currently affected by the coronavirus 2019-nCoV pandemic, whose immediate prognosis is linked to the development of acute respiratory distress syndrome (ARDS). Beyond the long-term adverse effects on respiratory health and reduced exercise capacity, other complications will occur. These include a more rapid progression of cardiometabolic diseases, a secondary epidemic of disabling post-traumatic stress disorder, and severe sleep disorders. The current project aims at a multidisciplinary assessment of respiratory, cardiac, sleep and mental health sequelae, three months after SARS-CoV-2 diagnosis in order to better characterize these complications.
Three aspects will be targeted in this study : (i) long-term monitoring of deterioration in lung function, (ii) screening for sleep respiratory disorders (sleep apnea syndrome, obesity hypoventilation syndrome) and iii) characterization of sleep disorders and design of specialized intervention to improve sleep quality.
This study is a prospective, multicentric cohort study that aims at constituting a cohort of 400 patients who will be screened for pulmonary, cardiac, sleep, or psychological sequelae 3 months after their diagnosis. They will be then followed for 5 years. The primary outcome will be the diffusion capacity of carbon monoxide (DLCO) 3 months after the diagnosis. Other secondary outcomes will include:
- prevalence of sleep disorders and sleep disordered breathing 3 months after diagnosis and their evolution until 5 years;
- prevalence of cardiac, exercise capacity, respiratory and ventilatory muscles impairments at 3 months and their evolution until 5 years;
- characterization of homogeneous groups of patients who were infected with SARS-CoV-2 and have respiratory, cardiometabolic and/or sleep complications, 3 months after diagnosis (latent class analysis) and evaluate their evolution until 5 years
- determine the prevalence of radiological sequelae at 3 months, and their evolution until 5 years
- determine the psycho-social impact (quality of life, post-traumatic stress, anxiety, productivity at work) at 3 months and its evolution until 5 years
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Renaud Tamisier, MD, PhD, MBA
- Número de teléfono: +33 476 768 469
- Correo electrónico: rtamisier@chu-grenoble.fr
Ubicaciones de estudio
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Bobigny, Francia, 93000
- Reclutamiento
- Hôpital Avicenne
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Contacto:
- Carole Planes, MD, Pr
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Créteil, Francia, 94000
- Reclutamiento
- Centre Hospitalier Henri Mondor, APHP
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Contacto:
- Genevieve Derumeaux, MD, Pr
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Grenoble, Francia, 38043
- Reclutamiento
- CHU Grenoble Alpes
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Sub-Investigador:
- Marie DESTORS, MD
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Contacto:
- Renaud Tamisier, MD, Pr, PhD
- Número de teléfono: (0033)476768469
- Correo electrónico: rtamisier@chu-grenoble.fr
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Sub-Investigador:
- Jean-Louis Pepin, MD, Pr, PhD
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Sub-Investigador:
- Sam Bayat, MD, Pr, PhD
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Sub-Investigador:
- Anne-Laure Mounayar, MD
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Sub-Investigador:
- Nicolas Terzi, MD, Pr
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Nancy, Francia, 54000
- Aún no reclutando
- CHRU Nancy
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Contacto:
- Bruno Chenuel, MD, Pr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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SARS-CoV-2 patients
Patients infected by SARS-CoV-2
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No Intervention.
The study consists in a prospective clinical longitudinal follow-up
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis
Periodo de tiempo: 3 months after COVID diagnosis
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Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO)
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3 months after COVID diagnosis
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis
Periodo de tiempo: 3 months after COVID diagnosis
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Prevalence of Sleep Disordered Breathing, as measured by polysomnography
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3 months after COVID diagnosis
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Prevalence of sleep disorders 3 months after COVID diagnosis
Periodo de tiempo: 3 months after COVID diagnosis
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Prevalence of sleep disorders, as measured by polysomnography
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3 months after COVID diagnosis
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Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis
Periodo de tiempo: 3 months after COVID diagnosis
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Prevalence of ventilatory impairments measured by pulmonary function tests
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3 months after COVID diagnosis
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Prevalence of cardiac impairments 3 months after COVID diagnosis
Periodo de tiempo: 3 months after COVID diagnosis
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Prevalence of cardiac impairments measured by cardiac echography
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3 months after COVID diagnosis
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Follow-up of pulmonary diffusion capacity of carbon monoxide
Periodo de tiempo: From Baseline (3 months after COVID diagnosis) to 5 years
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Pulmonary function as measured by diffusion capacity of carbon monoxide (DLCO)
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From Baseline (3 months after COVID diagnosis) to 5 years
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Follow-up of sleep disorders treatment compliance
Periodo de tiempo: From Baseline (3 months after COVID diagnosis) to 5 years
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Assessment of SDB treatments adherence will be monitored in hours/night
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From Baseline (3 months after COVID diagnosis) to 5 years
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Follow-up of sleep disorders treatments efficacy
Periodo de tiempo: From Baseline (3 months after COVID diagnosis) to 5 years
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Assessment of SDB treatments efficacy will be based on the residual AHI index (Apnea Hypopnea/hour) under treatment
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From Baseline (3 months after COVID diagnosis) to 5 years
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HLA alleles aspect of COVID clinical presentation
Periodo de tiempo: 3 months after COVID diagnosis
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HLA alleles will be assessed as a component of genetic immune capacity
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3 months after COVID diagnosis
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KIR loci aspect of COVID clinical presentation
Periodo de tiempo: 3 months after COVID diagnosis
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KIR loci will be assessed as a different component of genetic immune capacity
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3 months after COVID diagnosis
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metabolomic aspect of COVID clinical presentation
Periodo de tiempo: 3 months after COVID diagnosis
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metabolome expression in sera
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3 months after COVID diagnosis
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Renaud Tamisier, MD, PhD, MBA, University Hospital Grenoble Aples
Publicaciones y enlaces útiles
Publicaciones Generales
- 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. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 38RC20.157
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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