Embolism in COVID-19 Positive Patients
Examining the Genetic Predisposition of Individuals Who Aggravated by Embolism in COVID-19 Positive Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study has conducted to find the possible links between genetic make up of ICU patients with severe Covid-19 and embolism. 13 polymorphisms and mutations that the investigators targeted are located on Factor II, Factor V, Factor XIII, MTHFR, angiotensin converting enzyme (ACE), endothelial cell protein C receptor (EPCR), and FGB. The investigators have found significant changes in the mutant allele frequencies in most of the factors.
The main workflow to study a point change on DNA sequence begins with DNA isolation from a biological material. In this case, we received blood samples in ethylenediaminetetraacetic acid (EDTA) tubes from ICU patients with severe Covid-19. The investigators hypothesis claims that genetic factors triggering thrombotic events might increase the severity of the diseases by inducing the risk of emboli.
After DNA isolation, desired loci on DNA were amplified via Polymerase Chain Reaction (PCR). Amplicons including the mutations and polymorphisms need to be purified before next generation sequencing (NGS).
The investigators analyze the data using Integrative Genomics Viewer (IGV) program and check the genetic profile (wt, het, mut). Some of the changes are meaningful by themselves while some other need to be considered as combinations. Compound heterozygosity and diagnosis for thrombophilia require cooccurrence of the changes.
To compare allelic frequencies, the investigators include the average of the data coming from more than 2000 individuals with no know thrombophilia cases. In the investigators focus cohort, the investigators have the data of 47 Covid-19 patients in ICU.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Cankaya
-
Ankara, Cankaya, Kalkun, 06510
- INTERGEN Genetics and Rare Diseases Diagnosis Research & Application Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Groups were assigned to determine the genetic factors that explain severity of COVID-19 infections. These genetic factors play role in thrombotic events in the body.
Case group involves ICU patients with emboli that suffer from severe COVID-19. The investigators expect to see some deviations from normal population regarding the mutations and polymorphisms related to thrombophilia. Control group is normal population representing the normal allelic frequencies of the determinant genetic factors.
Beskrivelse
Inclusion Criteria:
- being tested positive for Covid-19
- ICU patients developing severe pneumonia upon Covid-19 infection
Exclusion Criteria:
- previously tested positive for genetic factors increasing thrombosis risk
- ICU patients developing severe emboli regardless of Covid-19 infection
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
ICU patients with severe COVID-19 pneumonia
Without using any intervention, this group has been included in the study to research certain genetic dispositions determining the severity of the COVID-19 pneumonia
|
|
Random population
This group has been included as a control group to compare the genetic predisposition of ICU patients with severe COVID-19 pneumonia with the normal population.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in allelic frequencies in predetermined loci which are known to be related with thrombosis
Tidsramme: 15.03.2021- 30.04.2021
|
In the first 28 samples the investigators received, we expected a predictive result revealing the genetic background and embolism in Covid-19.
Deviations from allelic frequencies of healthy population regarding some of the factors will support the hypothesis of the study.
|
15.03.2021- 30.04.2021
|
|
An increase in thrombophilia cases in the study group
Tidsramme: 01.05.2021- 20.05.2021
|
Thrombophilia is a complex state with the contribution of several factors.
Clinical picture and the mutations enable the diagnosis.
With an expanded study group consisting of 47 patients, we determined the patients with thrombophilia.
|
01.05.2021- 20.05.2021
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Serdar Ceylaner, Assoc. Prof., INTERGEN Genetics and Rare Diseases Diagnosis Research & Application Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Lungesygdomme
- Sygdomsegenskaber
- Embolisme og trombose
- COVID-19
- Embolisme
- Sygdomsmodtagelighed
- Genetisk disposition for sygdom
Andre undersøgelses-id-numre
- 2021-1
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .