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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 junho de 2021 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Antecipado)

500

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
      • Le Kremlin-Bicêtre, França, 94270
        • Recrutamento
        • Bicetre Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Outro: 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

Outro: 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.
Outro: 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

Outro: 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

O que o estudo está medindo?

Medidas de resultados primários

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 6 months
risk factors for the various sequelae of COVID-19
6 months
Association between patient characteristics and the prevalence of residual symptoms.
Prazo: 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
Prazo: 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.
Prazo: 6 months
residual symptoms of COVID-19 one year after COVID-19 that occurred during the 1st epidemic wave
6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Assistance Publique - Hôpitaux de Paris

Investigadores

  • Investigador principal: Tai PHAM, Bicetre Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de maio de 2021

Conclusão Primária (Antecipado)

5 de maio de 2022

Conclusão do estudo (Antecipado)

5 de maio de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

18 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de junho de 2021

Primeira postagem (Real)

22 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de junho de 2021

Última verificação

1 de junho de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • COMEBAC 2

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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