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Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France (COMEBAC 2)

18 de junio de 2021 actualizado por: Assistance Publique - Hôpitaux de Paris

Cohort Follow-up at 6-12 Months of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic From a University Hospital in France

From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

From 15th July to 18th September, 2020, in a first uncontrolled cohort study (Multi-Expertise Consultation of Bicêtre After Covid-19, COMEBAC), we evaluated at four months the surviving patients who were hospitalized at the Bicêtre hospital for COVID-19 during the 1st wave of the epidemic in France and having survived this hospitalization. This cohort included 478 patients. The article resulting from the analysis of the data collected is accepted for publication in JAMA.

This evaluation, the aim of which was both clinical and scientific, was carried out largely thanks to human and material resources then demobilized because of the epidemic and thanks to the investment of doctors and psychologists who carried out the work in addition to their usual work.

The response to the current call for projects aims to bring together the means to continue this monitoring work during the 2nd epidemic wave, while the means and staff are this time completely mobilized by the care of patients with COVID-19 and other. It also aims to raise funds that will allow an in-depth analysis of the residual symptoms presented by the patients.

The current project aims to continue the work started with the COMEBAC "1st wave" cohort with:

  • The inclusion of patients hospitalized after the 1st wave.
  • An assessment of symptoms according to the SARS-CoV-2 variant.
  • A 12-month follow-up of symptomatic patients during the evaluation in COMEBAC "1st wave".

Tipo de estudio

De observación

Inscripción (Anticipado)

500

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Tai PHAM
  • Número de teléfono: +33145217245
  • Correo electrónico: tai.pham@aphp.fr

Ubicaciones de estudio

  • Francia
      • Le Kremlin-Bicêtre, Francia, 94270
        • Reclutamiento
        • Bicetre Hospital
        • Contacto:
          • Tai PHAM
          • Número de teléfono: 0145217245
          • Correo electrónico: tai.pham@aphp.fr

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients from the 1st epidemic wave Patients from the 2nd epidemic wave

Descripción

For the 6-month evaluation of patients from the 2nd epidemic wave

  • Inclusion criteria

    • Age ≥18 years old
    • COVID-19 defined either by a reverse transcriptase-polymerase chain reaction (RT-PCR) or by a combination of clinical signs and compatible lung CT scan
    • Hospitalization for COVID-19 after 1st July 2020
    • Living out of the hospital

  • Exclusion criteria

    • Death occurring between index hospitalization and reassessment
    • Patient refusal
    • Discovery of a positive RT-PCR for SARS-CoV-2 during hospitalization for a reason other than COVID-19
    • Nosocomial COVID-19

For the 12-month evaluation of patients from the 1st epidemic wave

  • Inclusion criteria

    ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"

  • Exclusion criteria

    • Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
    • Patient refusal

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Patients from the 1st epidemic wave
One year after their discharge from the initial hospitalization, patients who presented symptoms during the evaluation in COMEBAC "1st wave" in summer 2020 will benefit from a telephone assessment on the same schedule as that detailed above. If symptoms persist, they will be called to the day hospital for an assessment similar to the one detailed above.
Otro: Teleconsultation

Teleconsulting physicians will subject patients to a standardized questionnaire that will look for the following symptoms:

  • General signs: Anorexia, fatigue, new hospitalization, weight loss,
  • Respiratory signs: recent dyspnoea, chest discomfort, chest pain, new cough, abnormal lung CT scan since discharge
  • Neurological signs: headache, paraesthesia, anosmia, limb paralysis
  • Digestive signs: abdominal pain, diarrhoea, constipation, nausea, vomiting

Edition 2021

◌ Cognitive signs using the Q3PC questionnaire (10): memory loss, slowness in reasoning, activity planning or problem solving, concentration, attention difficulties

Otro: Outpatient clinic

During a day hospitalization planned during the teleconsultation, patients will benefit from the following multidisciplinary assessment.

  • General clinical examination
  • Assessment of the state of health
  • Respiratory assessment
  • Pulmonary CT assessment
  • Cognitive evaluation
  • Cardiological evaluation
  • Renal assessment
  • Immunological evaluation
Patients from the 2nd epidemic wave

As during the evaluation carried out during the 1st wave, the detection of persistent symptoms will be done in two stages:

  • During a teleconsultation, to which all eligible patients will be invited, systematically looking for general, neurological, cognitive and respiratory symptoms
  • During a hospitalization in an outpatient clinic to which all survivors who have stayed in an intensive care unit (ICU) will be invited and, among patients who have not stayed in an ICU, those who have residual symptoms detected during the teleconsultation.
Otro: Teleconsultation

Teleconsulting physicians will subject patients to a standardized questionnaire that will look for the following symptoms:

  • General signs: Anorexia, fatigue, new hospitalization, weight loss,
  • Respiratory signs: recent dyspnoea, chest discomfort, chest pain, new cough, abnormal lung CT scan since discharge
  • Neurological signs: headache, paraesthesia, anosmia, limb paralysis
  • Digestive signs: abdominal pain, diarrhoea, constipation, nausea, vomiting

Edition 2021

◌ Cognitive signs using the Q3PC questionnaire (10): memory loss, slowness in reasoning, activity planning or problem solving, concentration, attention difficulties

Otro: Outpatient clinic

During a day hospitalization planned during the teleconsultation, patients will benefit from the following multidisciplinary assessment.

  • General clinical examination
  • Assessment of the state of health
  • Respiratory assessment
  • Pulmonary CT assessment
  • Cognitive evaluation
  • Cardiological evaluation
  • Renal assessment
  • Immunological evaluation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.
Periodo de tiempo: 6 months
nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference between the prevalence of residual symptoms between patients hospitalized during the 1st wave of the epidemic in France (from the COMEBAC "1st wave" study) and those of the current study
Periodo de tiempo: 6 months
risk factors for the various sequelae of COVID-19
6 months
Association between patient characteristics and the prevalence of residual symptoms.
Periodo de tiempo: 6 months
effect of the therapeutic changes that occurred between the 1st and 2nd wave of COVID-19 on these persistent symptoms.
6 months
Association between residual symptoms and the type of SARS-CoV-2 variant
Periodo de tiempo: 6 months
residual symptoms of COVID-19 according to the SARS-CoV-2 variants responsible
6 months
Prevalence of respiratory, neurological, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19 which occurred during the 1st epidemic wave.
Periodo de tiempo: 6 months
residual symptoms of COVID-19 one year after COVID-19 that occurred during the 1st epidemic wave
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Assistance Publique - Hôpitaux de Paris

Investigadores

  • Investigador principal: Tai PHAM, Bicetre Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de mayo de 2021

Finalización primaria (Anticipado)

5 de mayo de 2022

Finalización del estudio (Anticipado)

5 de mayo de 2022

Fechas de registro del estudio

Enviado por primera vez

18 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2021

Publicado por primera vez (Actual)

22 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • COMEBAC 2

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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