Epigenetic Tools as Prognostic Predictors in Covid19

NCT04411563 | Unknown DMC

• 1 other identifier: 2020/143
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The necessity for early detection and hence improving the outcome of treatment of pneumonia is critical especially SARS-CoV-2 induced cases. This work was designed to evaluate the potential application of measuring circulating epigenetic markers namely, miR-744, miR-24, miR-124, miR-155, miR-19a, miR-122, miR-21, miR-223, let-7f, miR-146, miR-196, miR-136, P13-K, miR-9 expression, and DNA methylation profiling of the ACE2, TMPRSS2, PARP, HOX1 genes in Coronavirus disease 2019 (COVID-19) due to SARS-CoV-2 with/without pneumonia and severe acute respiratory syndrome (SARS) patients as an attempt to evaluate the potential benefits of these new circulating, prognostic, epigenetic markers for Turkish patients.

Conditions

Prognosis

Keywords

COVID 19; Prognostic Epigenetics; miRNA; DNA methylation

Outcome Measures

Primary Outcomes (1)

• Determination of the relationship between the severity of disease and epigenetic factors in COVID 19

  Analysis of pathway-related micro RNAs in patients with mild, moderate and severe Covid 19 clinics

  Seven months

Study Arms (3)

Group I-Mild

The patients who have these mild symptoms are low-grade fever (not more than 38 degrees celsius), dry cough, fatigue, sore throat, headache, the new loss of taste, and smell. Patients with normal or mild pneumonia findings of radiological imaging and blood lymphocyte count ≥800 / µl and serum CRP≤40 mg /l, ferritin ≤500ng/ml, D-Dimer ≤1000 ng/ml will be included in group I.

Other: Taking biological samples

Group II-Moderate

The patients who have these moderate symptoms are fever of about 38,5-39 degrees celsius, chills, deep cough, fatigue and body aches, muscle pain, the general feeling of being unwell. Patients with bilateral diffuse pneumonia findings of radiological imaging or blood lymphocyte count \<800 / µl or serum CRP\> 40 mg / l or ferritin\> 500ng / ml or D-Dimer\> 1000 ng / ml will be included in group II.

Other: Taking biological samples

Group III-Severe

The patients who have these severe symptoms are all the common symptoms mentioned above along with shortness of breath, chest discomfort, confusion/unresponsiveness, bluish face/lips, possible gastrointestinal issues, like diarrhea or nausea. Patients with ICU (intensive care unit) admission criteria, such as confusion or tachycardia (\> 125 / min) or respiratory distress or tachypnea (\> 22 / min) or hypotension \<90/60 mmHg or SPO2 \<93%will be included in group III. Also, patients with the central nervous system and heart involvement will be directly included in the severe case group

Other: Taking biological samples

Interventions

Taking biological samples OTHER

Taking blood samples for biochemical and epigenetic analysis

Group I-Mild; Group II-Moderate; Group III-Severe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

On the basis of the inclusion and exclusion criteria 105 patients subjects will be included in this study, divided into three groups; group I (n = 35) patients are mild, group II (n = 35) patients are moderate, and group III (n = 35) patients are severe and critical. Mild and moderate cases are usually defined as those without severe pneumonia or sever acute respiratory syndrome.

You may qualify if:

• All patients between the ages of 18 and 65 included will suffer from COVID 19, and specific treatment should not yet be initiated.
• COVID 19 diagnosis of patients will be based on full medical history, thorough clinical examination, radiological imaging, laboratory assessment, and SARS-CoV-2 analysis by RT-PCR.

You may not qualify if:

• People with chronic lung disease or previous AC surgery
• People with immune deficiency or cancer patients
• Patients receiving immunosuppressive therapy for autoimmune disease
• People with neurological diseases affecting the respiratory muscles, such as hypotonia.

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead
• Istanbul University: collaborator

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genomic material will be stored to continue prognostic biomarker studies.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

• Gokhan T. Adas, Prof

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  STUDY DIRECTOR

• Asuman Gedikbasi, Assoc.Prof.

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Kadriye Yaşar, Prof.

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Nilgün Isiksacan, Assoc.Prof.

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Zafer Çukurova, Assoc.Prof.

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Oya G. Hergünsel, MD, Intensivist

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Sacide Pehlivan, Prof.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asuman Gedikbasi, Assoc.Prof.

CONTACT

00905327009660; asugedikbasi@yahoo.com

Gokhan T Adas, Prof.

CONTACT

00905326155892; gokhantolgaadas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Member

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 2, 2020
• Study Start: May 21, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

TU (1)