Embolism in COVID-19 Positive Patients

NCT04910360 | Unknown

• 1 other identifier: 2021-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Covid-19 outbreak has caused death of millions of people because of not only the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection itself but also infection dependent complications. Abnormalities in thrombotic events leads to some of these complications which eventually result in emboli. The endothelial damage caused by the virus interacting with ACE2 on the host cells leads to the activation of coagulation cascade. Accumulation of byproducts of the cascade might have some roles in embolism inducing risk of organ damage, other life-threatening problems, and even death. To enlighten the factors triggering embolism, the investigators have focused on genetic changes such as polymorphisms and mutations in certain genes in DNA samples coming from intensive care unit (ICU) patients.

Conditions

COVID-19 Pneumonia; Embolism; Genetic Predisposition

Keywords

thrombophilia; genetic factors; COVID-19

Outcome Measures

Primary Outcomes (2)

• Changes in allelic frequencies in predetermined loci which are known to be related with thrombosis

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• being tested positive for Covid-19
• ICU patients developing severe pneumonia upon Covid-19 infection

You may not qualify if:

• previously tested positive for genetic factors increasing thrombosis risk
• ICU patients developing severe emboli regardless of Covid-19 infection

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

INTERGEN Genetics and Rare Diseases Diagnosis Research & Application Center

Ankara, Cankaya, 06510, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

3 ml blood samples and extracted DNA from blood samples are stored.

MeSH Terms

Conditions

Embolism; Genetic Predisposition to Disease; Thrombophilia; COVID-19

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Serdar Ceylaner, Assoc. Prof.

  INTERGEN Genetics and Rare Diseases Diagnosis Research & Application Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 2, 2021
• Study Start: March 5, 2021
• Primary Completion: May 8, 2021
• Study Completion: August 30, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

TU (1)