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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Moscow, Russische Federatie, 129226
- Werving
- Russian Clinical Research Center for Gerontology
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Contact:
- Olga Tkacheva, MD, PhD
- E-mail: rgnkc@rgnkc.ru
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The presense of postcovid syndrome
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pathological changes in lung tissue according to CT data
Tijdsspanne: 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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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- COVID_2020_01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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