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Идёт набор NCT04392401

COVID-19 - Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study

— Наблюдательное Intensive Care Unit SARS-Cov-2

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Collection of blood samples in order to create a biocollection.
Кому может быть актуально
Состояния в реестре: Intensive Care Unit, SARS-Cov-2. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study

Обзор

Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpes region (AURA), the epidemic began in February 2020 and the number of infected people is still important. Between 15 and 20% of COVID-19 patients develop an acute respiratory distress syndrome (ARDS) leading to their hospitalization in intensive care. Their clinical progression can be rapidly harmful with the development of severe ARDS associated with an increased risk of death. Preliminary data on the immune response of COVID-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. Up to 50% of secondary infections are reported in deceased COVID-19 patients. However, no prospective study has exhaustively described the kinetics of the immune response of COVID-19 patients in intensive care. The precise description of the immune response over time in adult patients with a proven infection with the SARS-CoV-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ARDS), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by COVID-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in COVID-19.

Вмешательства

  • Биопрепарат Collection of blood samples in order to create a biocollection
    Blood samples will be collected at admission in intensive care, at Day 3, Day 7, Day 12 and Day 20 during their hospitalization. Clinical data from routine care will be collected. Vital status will be assessed at Day 28 and Day 90.

Первичные конечные точки

  • Kinetics over time of HLA-DR expression on the surface of monocytes [Срок оценки: Along the intensive care stay, an average of 20 days]

Критерии участия

Критерии включения

  • Man or woman aged 18 or over,
  • Hospitalization in intensive care for Sars-Cov-2 pneumopathy,
  • First hospitalization in intensive care unit,
  • Positive diagnosis of SARS-CoV2 infection carried out by PCR or by another approved method in at least one respiratory sample,
  • Sampling in the first 24 hours after admission to intensive care unit (D0 / D1) feasible,
  • Patient or next of kin who has been informed of the terms of the study and has not objected to participating.

Критерии исключения

  • Pregnant or lactating woman,
  • Person placed under legal protection,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 8 центров
  • Hôpital Pierre Wertheimer — Bron
  • Hôpital Gabriel Montpied — Clermont-Ferrand
  • Centre hospitalier universitaire de Grenoble Alpes — Grenoble
  • Hôpital Edouard Herriot — Lyon
  • Hôpital Edouard Herriot — Lyon
  • Hôpial de la Croix Rousse — Lyon
  • Hôpital Lyon Sud — Pierre-Bénite
  • CH de St Etienne — Saint-Etienne

Публикации

  • Baudemont G, Tardivon C, Monneret G, Cour M, Rimmele T, Garnier L, Yonis H, Richard JC, Coudereau R, Gossez M, Wallet F, Delignette MC, Dailler F, Buisson M, Lukaszewicz AC, Argaud L, Laouenan C, Bertrand J, Venet F; RICO study group. Joint modeling of monocyte HLA-DR expression trajectories predicts 28-day mortality in severe SARS-CoV-2 patients. CPT Pharmacometrics Syst Pharmacol. 2024 Jul;13(7) PMID 38837680
  • Bidar F, Hamada S, Gossez M, Coudereau R, Lopez J, Cazalis MA, Tardiveau C, Brengel-Pesce K, Mommert M, Buisson M, Conti F, Rimmele T, Lukaszewicz AC, Argaud L, Cour M, Monneret G, Venet F; RICO Study Group. Recombinant human interleukin-7 reverses T cell exhaustion ex vivo in critically ill COVID-19 patients. Ann Intensive Care. 2022 Mar 5;12(1):21. doi: 10.1186/s13613-022-00982-1. PMID 35246776

Идентификаторы

NCT: NCT04392401 · 69HCL20_0358 · 2020-A01079-30

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗