Embolism in COVID-19 Positive Patients
Examining the Genetic Predisposition of Individuals Who Aggravated by Embolism in COVID-19 Positive Patients
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Cankaya
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Ankara、Cankaya、七面鳥、06510
- INTERGEN Genetics and Rare Diseases Diagnosis Research & Application Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Changes in allelic frequencies in predetermined loci which are known to be related with thrombosis
時間枠：15.03.2021- 30.04.2021
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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.
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15.03.2021- 30.04.2021
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An increase in thrombophilia cases in the study group
時間枠：01.05.2021- 20.05.2021
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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.
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01.05.2021- 20.05.2021
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協力者と研究者
捜査官
- スタディディレクター：Serdar Ceylaner, Assoc. Prof.、INTERGEN Genetics and Rare Diseases Diagnosis Research & Application Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2021-1
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。