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Epigenetic Tools as Prognostic Predictors in Covid19

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ClinicalTrials.gov Identifier: NCT04411563
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Istanbul University
Information provided by (Responsible Party):
Gokhan Tolga Adas, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Condition or disease Intervention/treatment
Prognosis Other: Taking biological samples

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Months
Official Title: The Effect of miRNA and Epigenetic Modifications on Prognosis in Covid-19 Infection
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
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
Taking blood samples for biochemical and epigenetic analysis

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
Taking blood samples for biochemical and epigenetic analysis

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
Taking blood samples for biochemical and epigenetic analysis




Primary Outcome Measures :
  1. Determination of the relationship between the severity of disease and epigenetic factors in COVID 19 [ Time Frame: Seven months ]
    Analysis of pathway-related micro RNAs in patients with mild, moderate and severe Covid 19 clinics


Biospecimen Retention:   Samples With DNA
Genomic material will be stored to continue prognostic biomarker studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411563


Contacts
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Contact: Asuman Gedikbasi, Assoc.Prof. 00905327009660 asugedikbasi@yahoo.com
Contact: Gokhan T Adas, Prof. 00905326155892 gokhantolgaadas@gmail.com

Locations
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Turkey
Bakirkoy Dr. Sadi Konuk Research and Training Hospital Recruiting
Istanbul, Turkey, 34147
Contact: Gokhan T. Adas, Prof.    00905326155892    gokhantolgaadas@gmail.com   
Contact: Asuman Gedikbasi, Assoc.Prof.    00905327009660    asugedikbasi@yahoo.com   
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul University
Investigators
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Study Director: Gokhan T. Adas, Prof Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Principal Investigator: 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
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Responsible Party: Gokhan Tolga Adas, Faculty Member, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT04411563    
Other Study ID Numbers: 2020/143
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Since studies on COVID 19 in our country during this pandemic are subject to certain permissions, the decision will be made when the permit processes are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gokhan Tolga Adas, Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
COVID 19
Prognostic Epigenetics
miRNA
DNA methylation