Идёт набор NCT04887623

Dynamics of Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients

— Наблюдательное COVID-19 Respiratory Infection

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: COVID-19 Respiratory Infection. Базовые параметры: 18 лет — 90 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: Чехия
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

Dynamics of Nucleocapsid Antigen Serum Levels and Other Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients - a Pilot Study

Обзор

Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load. Several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load. In this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with COVID-19.

Подробное описание

In this pilot study, 30 consecutive COVID-19 patients requiring admission to the hospital due to a moderate and severe COVID-19 infection will be included into an observational study.

Following parameters will be recorded: age, sex, weight, height, comorbidities, smoking habit,spiritus and drug intake history, length of COVID-19 symptoms, clinical and laboratory parameters, the use of different COVID-19 intervention (remdesivir, convalescent plasma, monoclonal antibodies, corticosteroids, tocilizumab and other medication), used initial and maximal organ support during the stay and outcome of the stay in the hospital and 28th and 90th day, laboratory markers of severity of infection - serum and tracheal aspirate (in ventilated patients) levels of nucleocapsid antigen,Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) viremia and quantity in tracheal aspirates (in ventilated patients), makers of inflammatory response (C- reactive proteins, Interleukin 6, procalcitonin, ferritin) and selected other biochemical values (blood count, D-dimers, flow cytometry).

Первичные конечные точки

Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels [Срок оценки: Admission]
Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels [Срок оценки: Admission]
Prediction of severity of lung dysfunction based on [Срок оценки: Admission]

Вторичные конечные точки (7)

Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels [Срок оценки: up to 28 days]
Effect of the remdesivir on the nucleocapsid antigen serum levels [Срок оценки: up to 28 days]
Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR [Срок оценки: up to 28 days]
Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR [Срок оценки: up to 28 days]
Effect of age on viral load assesed using nucleocapsid antigen serum levels [Срок оценки: up to 28 days]
Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels [Срок оценки: up to 28 days]
Tracheal viral load quantification using tracheal nucleocapsid antigen [Срок оценки: up to 28 days]

Критерии участия

Критерии включения

SARS CoV2 positive test within last 14 day
bilateral infiltrates on chest X.ray or CT
need for oxygen to keep pulse oximetry saturation above 92% or other respiratory support measures (HFNO, non-invasive ventilation or invasive ventilation)