Late Clinical Events Associated With COVID-19 Infection (COCO-LATE)
Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
Several publications document the occurrence of symptoms that persist or occur late.
The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Several publications document the occurrence of symptoms that persist or occur late, more than 3 weeks after the first clinical manifestations of an SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory complications, superinfections, or other mechanisms not yet well understood, including potentially related to the persistence of SARS-COV2. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a COVID-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for COVID-19, still symptomatic or not at 3 weeks of infection.
Longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Olivier ROBINEAU, MD PhD
- Telefonnummer: 0320694949
- E-post: orobineau@ch-tourcoing.fr
Studiesteder
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Auxerre, Frankrike
- Rekruttering
- CH Auxerre
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Caen, Frankrike
- Rekruttering
- CHU Caen
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Lille, Frankrike
- Rekruttering
- CHRU Lille
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Melun, Frankrike
- Rekruttering
- CH Melun Marc Jacquet
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Nemours, Frankrike
- Rekruttering
- CH Sud Seine et Marne
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Paris, Frankrike
- Har ikke rekruttert ennå
- AP-HP Hôpital Hôtel-Dieu
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Saint-Priest-en-Jarez, Frankrike
- Rekruttering
- CHU de Saint-Etienne
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Tourcoing, Frankrike
- Rekruttering
- CH Tourcoing
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Tours, Frankrike
- Rekruttering
- Chru Tours
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Vandœuvre-lès-Nancy, Frankrike
- Rekruttering
- CHRU NANCY
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Vannes, Frankrike
- Rekruttering
- Centre Hospitalier Bretagne Atlantique
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Cayenne, Fransk Guyana
- Rekruttering
- CH André Rosemon de Cayenne
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
History of symptomatic CoV-2-SARS infection as defined by :
o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
o Associated with at least one event : x Anosmia occurring after February 2020 x OR COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present prior to diagnosis
- AND persistence of at least one symptom present in the first 3 weeks of a COVID-19, more than 8 weeks away from the first symptoms of COVID-19. OR late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a CoV-2 SARS infection.
- First symptoms less than 6 months old on the day of inclusion
- To benefit from a State Health Insurance or Medical Aid plan
- Have signed an informed consent for inclusion.
Exclusion Criteria:
- Minor patient
- Patient under protection of justice
Patient who required intensive care management :
- more than 5 days
- OR requiring orotracheal intubation
- OR having required high flow ventilation (optiflow)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Standardized clinical and paraclinical follow-up
Standardized clinical and paraclinical follow-up will be offered in one of the referring investigator centers. Patients will be able to benefit from additional biological samples. Questionnaires will be completed by the patient or with the help of clinical research staff in paper format. All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID. Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits. Total serum, plasma and naso-paaryngeal samples will be collected. |
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Total serum, plasma samples will be collected
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical description of asthenia
Tidsramme: At the end od the study, an average of 22 months
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Describe the frequence of asthenia between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
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At the end od the study, an average of 22 months
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Clinical description of dyspnea
Tidsramme: At the end od the study, an average of 22 months
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Frequence of dyspnea between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
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At the end od the study, an average of 22 months
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Clinical description of thoracic disorders
Tidsramme: At the end od the study, an average of 22 months
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Frequence of thoracic disorders between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
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At the end od the study, an average of 22 months
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Clinical description of neurological disorders
Tidsramme: At the end od the study, an average of 22 months
|
Frequence of neurological disorders between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
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At the end od the study, an average of 22 months
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Clinical description of anosmia
Tidsramme: At the end od the study, an average of 22 months
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Frequence of anosmia disorders between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
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At the end od the study, an average of 22 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Olivier ROBINEAU, MD PhD, CH Tourcoing
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RIPH_2020_09
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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