Corona Virus Infection Among Liver Transplant Recipients
Corona Virus Infection Among Liver Transplant Recipients: A Multicenter Study
A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020.
The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on.
Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic.
Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm.
Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2.
The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia.
They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases.
Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization.
Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.
調査の概要
状態
詳細な説明
- Liver Transplant recipients in 3 liver transplant centers will answer survey including 21 questions (14 questions covers the demographic data, date since the operation and immunosuppressant medications and 11 questions related to Corona virus infection). (SARS-CoV-2 infection will be defined according to the Ministry of Health and population definitions of suspected and confirmed cases).
- Doing serological test searching for Neutralizing Ab against SARS-Corona virus 2 in the liver transplant recipients who accepted to give blood sample.
(It can be detected by Electrochemiluminescence immunoassay (ECLIA) method.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Assiut、エジプト
- 募集
- Assiut University
-
コンタクト：
- Nahed Makhlouf, Professor
- 電話番号：01003611626
- メール：nahedmak@yahoo.com
-
コンタクト：
- Mohamed A Medhat, MD
- 電話番号：01000493632
- メール：mmedhat83@gmail.com
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副調査官：
- Amal A Mahmoud, MD
-
副調査官：
- Mohammed A Medhat, MD
-
副調査官：
- Bashir A Fadel, MD
-
主任研究者：
- Nahed A Makhlouf, Professor
-
副調査官：
- Rasha O Refaay, Professor
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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
説明
Inclusion Criteria:
-Liver transplant recipients in 3 Liver Transplant Centers in Egypt and who accept to participate in the study
Exclusion Criteria:
- Those who refuse to participate in the study.
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
- 観測モデル：コホート
- 時間の展望：断面図
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 |
時間枠 |
|---|---|
|
The occurrence of corona virus infection (confirmed or suspected) among liver transplant recipients
時間枠：1 month
|
1 month
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
The presence of Neutralizing Ab against SARS-Corona virus 2 among liver transplant recipients whether who give symptoms for corona virus or asymptomatic and who accept to give blood sample
時間枠：2 month
|
2 month
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 17300475
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。
COVID-19（新型コロナウイルス感染症）の臨床試験
-
Pfizer積極的、募集していないCOVID-19（新型コロナウイルス感染症） | コロナウイルス病 2019 (COVID-19) | COVID-19 感染 | COVID-19 ワクチン | SARS-CoV-2 感染、COVID19 | COVID-19 ワクチン接種 | SARS-CoV-2 感染、COVID-19 | COVID-19 (コロナウイルス病 2019) | COVID-19 SARS-CoV-2 感染症アメリカ
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Pfizer募集気道疾患 | COVID-19（新型コロナウイルス感染症） | 肺炎 | 肺疾患 | コロナウイルス 病気 2019年 | コロナウイルス病 2019 (COVID-19) | COVID-19 感染 | 上気道感染症 | 気道感染症 | COVID-19 (コロナウイルス病 2019) | COVID-19 SARS-CoV-2 感染症ベルギー
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ModeX Therapeutics, An OPKO Health Company募集
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Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Eggensberger OHGBavarian Health and Food Safety Authority (LGL)募集COVID-19 後の状態 | COVID-19 後 | COVID-19 後症候群 | 長い COVID-19 症候群 | COVID-19 後の状態 (PCC)ドイツ
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Indonesia University募集COVID-19後症候群 | 長い COVID | COVID-19 後の状態 | COVID後症候群 | 長い COVID-19インドネシア
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Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, Indonesia募集COVID-19 パンデミック | COVID-19 ワクチン | COVID-19 ウイルス病インドネシア
-
University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)積極的、募集していない
-
Yang I. Pachankis積極的、募集していないCOVID-19 呼吸器感染症 | COVID-19 ストレス症候群 | COVID-19 ワクチンの副作用 | COVID-19 関連の血栓塞栓症 | COVID-19 集中治療後症候群 | COVID-19 関連の脳卒中中国