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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. juni 2021 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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".

Undersøgelsestype

Observationel

Tilmelding (Forventet)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Le Kremlin-Bicêtre, Frankrig, 94270
        • Rekruttering
        • Bicetre Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: 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

Andet: 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.
Andet: 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

Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.
Tidsramme: 6 months
nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 6 months
risk factors for the various sequelae of COVID-19
6 months
Association between patient characteristics and the prevalence of residual symptoms.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 6 months
residual symptoms of COVID-19 one year after COVID-19 that occurred during the 1st epidemic wave
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Ledende efterforsker: Tai PHAM, Bicetre Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. maj 2021

Primær færdiggørelse (Forventet)

5. maj 2022

Studieafslutning (Forventet)

5. maj 2022

Datoer for studieregistrering

Først indsendt

18. juni 2021

Først indsendt, der opfyldte QC-kriterier

18. juni 2021

Først opslået (Faktiske)

22. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COMEBAC 2

Plan for individuelle deltagerdata (IPD)

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