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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 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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".

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Frankreich
      • Le Kremlin-Bicêtre, Frankreich, 94270
        • Rekrutierung
        • Bicetre Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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

Sonstiges: 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.
Sonstiges: 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

Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.
Zeitfenster: 6 months
nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization
6 months

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Ermittler

  • Hauptermittler: Tai PHAM, Bicetre Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Mai 2021

Primärer Abschluss (Voraussichtlich)

5. Mai 2022

Studienabschluss (Voraussichtlich)

5. Mai 2022

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2021

Zuerst gepostet (Tatsächlich)

22. Juni 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juni 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juni 2021

Zuletzt verifiziert

1. Juni 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • COMEBAC 2

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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