Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19 (OPTIMIST)
200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to SARS-CoV-2.
The study consists of two visits. At the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study.
At the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing.
The aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection COVID-19. Clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to CT data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Moscow, Federación Rusa, 129226
- Reclutamiento
- Russian Clinical Research Center for Gerontology
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Contacto:
- Olga Tkacheva, MD, PhD
- Correo electrónico: rgnkc@rgnkc.ru
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
For all groups:
- Informed consent signed by the patient.
- Men and women aged 18 and over.
Group COVID-19 (asymptomatic):
- Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
- Absence of any clinical symptoms associated with coronavirus infection.
Group Healthy:
- Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
- Absence of any clinical symptoms associated with coronavirus infection
Group COVID symptomatic:
- Confirmed diagnosis of previous COVID-19 (positive SARS-CoV-2 RNA PCR test or presence of IgM antibodies to SARS-CoV-2) in history.
A severe course of COVID-19, characterized by one or more of the following symptoms:
- Respiratory rate ≥ 30 in 1 min
- Blood oxygen saturation (SpO2) ≤ 93%
- The ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (PaO2 / FiO2) <300
- Lung tissue lesion> 50% and / or according to computed tomography CT-2 and higher
- Septic shock / sepsis
- Development of multiple organ failure
- Cytokine storm
Exclusion Criteria:
- Pregnancy
- Covid-19 vaccination
- Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
- Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
- Refusal to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients with severe COVID-19 pneumonia
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All patients will undergo a comprehensive examination to identify the consequences of COVID-19
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Patients who had an asymptomatic COVID-19 3 months ago
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All patients will undergo a comprehensive examination to identify the consequences of COVID-19
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People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick
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All patients will undergo a comprehensive examination to identify the consequences of COVID-19
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The presense of postcovid syndrome
Periodo de tiempo: through study completion, an average of 3 months
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Clinical and laboratory indicators The number and severity of signs of postcovid syndrome
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through study completion, an average of 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pathological changes in lung tissue according to CT data
Periodo de tiempo: through study completion, an average of 3 months
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CT scan
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through study completion, an average of 3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- COVID_2020_01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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