- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04871789
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Moscow, Den Russiske Føderation, 129226
- Rekruttering
- Russian Clinical Research Center for Gerontology
-
Kontakt:
- Olga Tkacheva, MD, PhD
- E-mail: rgnkc@rgnkc.ru
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Patients with severe COVID-19 pneumonia
|
All patients will undergo a comprehensive examination to identify the consequences of COVID-19
|
Patients who had an asymptomatic COVID-19 3 months ago
|
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
|
All patients will undergo a comprehensive examination to identify the consequences of COVID-19
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The presense of postcovid syndrome
Tidsramme: through study completion, an average of 3 months
|
Clinical and laboratory indicators The number and severity of signs of postcovid syndrome
|
through study completion, an average of 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pathological changes in lung tissue according to CT data
Tidsramme: through study completion, an average of 3 months
|
CT scan
|
through study completion, an average of 3 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COVID_2020_01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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