COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience
2020年9月19日 更新者：Mona Hegazy、Cairo University
Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center Experience
The present study conducted to correlate symptoms not only constitutional and respiratory, but GIT as a principle presentation, with laboratory markers and COVID-19 severe acute respiratory syndrome (SARS-COV2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict COVID-19 outcomes based on real-time experience.
調査の概要
詳細な説明
This observational retrospective cohort single center national study was conducted on patients who tested positive COVID-19 infection by the polymerase chain reaction (PCR) of nasopharyngeal sample in the period from first June to the med of July 2020. Patients were recruited from Kasr Al-Aini School of medicine, COVID-19 out-patient clinic, Cairo University hospitals.
The diagnosis and classification of severity of COVID-19 infection were made according to the clinical management of COVID-19, released by the World Health Organization (WHO), mild and moderate case were recruited, the treatment protocol used was according to the Egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, Mild and moderate cases once diagnosed by PCR received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. Steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms.
Any adult patient (age ≥18 years) suffering from mild or moderate COVID-19 infection was included in this study. While severe cases according to WHO classifications and patients aged less than18 were excluded from the study.
研究の種類
観察的
入学 (実際)
199
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cairo、エジプト
- Faculty of Medicine Cairo University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients was recruited from COVID19 out-patient clinic, Cairo University hospitals.
Severity Classification made according to the WHO (13) and Egyptian ministry of health treatment recommendations (14) Clinical data was collected including patient demographics (age, gender, weight and height, body mass index, comorbid conditions (e.g.diabetes mellitus, chronic pulmonary disease), vital signs.
Clinical symptoms were recorded using yes/no checklist about constitutional symptoms, respiratory symptoms, loss of taste, loss of smell and gastrointestinal symptoms.The patients were followed up daily; by telehealth through phone calls and commercial video chat platforms, till symptoms offset.
Laboratory assessment was collected within 24 hours of symptoms onset (complete blood picture, kidney and liver biochemistry, random blood sugar, serum C-reactive protein, D-dimer, ferritin, lipid profile, and lactate dehydrogenase).
CT chest was performed and its result was recorded
説明
Inclusion Criteria:
- Mild and moderate COVID-19 patients:
Exclusion Criteria:
- Age less than 18 years
- Severe COVID-19 patients: with dyspnea, hypoxia, or >50 percent lung involvement on imaging within 24 to 48 hours
- Critical COVID-19 patients: with respiratory failure, shock, or multiorgan dysfunction
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：回顧
コホートと介入
グループ/コホート |
介入・治療 |
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Group 1
Duration of COVID-19 symptoms less than 12 days
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hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases.
Also they received anticoagulants, vitamin c and zinc.
In case of secondary bacterial infection, empiric antibiotics are started
他の名前：
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Group 2
Duration of COVID-19 symptoms equal or more than 12 days
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hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases.
Also they received anticoagulants, vitamin c and zinc.
In case of secondary bacterial infection, empiric antibiotics are started
他の名前：
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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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COVID-19 disease spectrum and duration
時間枠：july 2020 to june 2020
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The investigators tried to correlate disease severity with disease duration
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july 2020 to june 2020
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GIT manifestations among COVID-19 patients
時間枠：july 2020 to june 2020
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spectrum of GIT manifestations in COVID-19 patients was investigated
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july 2020 to june 2020
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Non-communicable disease and COVID-19
時間枠：july 2020 to june 2020
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The link between non-communicable disease (including diabetes, hypertension and Hypercholesterolemia) severity and COVID-19 prognosis
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july 2020 to june 2020
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Seasonal change and COVID-19
時間枠：july 2020 to june 2020
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the investigators studied the Impact of weather climate on COVID-19 presentations (higher incidence of diarrhea in COVID-19 patients in summer) and outcomes
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july 2020 to june 2020
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Possible region specific classification for COVID-19 disease
時間枠：july 2020 to june 2020
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The investigators tried to find new Egyptian classification fro COVID-19 disease severity
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july 2020 to june 2020
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Mona M Hegazy, MD、Professor of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
- スタディディレクター：Ahmed M Abdul Ghani, MD、Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
- スタディチェア：Rania M Lithy, MD、Lecturer of Endemic medicine and hepatogastroenterology. Faculty of medicine Cairo University
- スタディチェア：Hoda M abdel-Hamid, MD、Lecturer of Respiratory medicine. Faculty of medicine Cairo University
- スタディチェア：Mahmoud Wahba, MD、Lecturer of Internal Medicine Division of Gastroenterology, Kasr Alainy . Faculty of Medicine, Cairo University
- スタディチェア：Omar Ashoush, MD、Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
- スタディチェア：Mohamed Tharwat Hegazy, MD、Lecturer of Internal Medicine Department, Rheumatology and Clinical Immunology unit, Faculty of Medicine, Cairo University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
- 1.World Health Organization. Novel coronavirus (2019-nCoV): situation report-40. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200229-sitrep-40-covid-19.pdf. Accessed 29 February 2020.
- Hoehl S, Rabenau H, Berger A, Kortenbusch M, Cinatl J, Bojkova D, Behrens P, Boddinghaus B, Gotsch U, Naujoks F, Neumann P, Schork J, Tiarks-Jungk P, Walczok A, Eickmann M, Vehreschild MJGT, Kann G, Wolf T, Gottschalk R, Ciesek S. Evidence of SARS-CoV-2 Infection in Returning Travelers from Wuhan, China. N Engl J Med. 2020 Mar 26;382(13):1278-1280. doi: 10.1056/NEJMc2001899. Epub 2020 Feb 18. No abstract available.
- Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
- Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.
- 9. Mo P, Xing Y, Xiao Y, et al. Clinical characteristics of refractory COVID-19 pneumonia in Wuhan, China. [published online ahead of print, 2020 Mar 16]. Clin Infect Dis 2020:ciaa270. doi:10.1093/ 54. cid/ciaa270
- D'Amico F, Baumgart DC, Danese S, Peyrin-Biroulet L. Diarrhea During COVID-19 Infection: Pathogenesis, Epidemiology, Prevention, and Management. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1663-1672. doi: 10.1016/j.cgh.2020.04.001. Epub 2020 Apr 8.
- Tian S, Chang Z, Wang Y, Wu M, Zhang W, Zhou G, Zou X, Tian H, Xiao T, Xing J, Chen J, Han J, Ning K, Wu T. Clinical Characteristics and Reasons for Differences in Duration From Symptom Onset to Release From Quarantine Among Patients With COVID-19 in Liaocheng, China. Front Med (Lausanne). 2020 May 12;7:210. doi: 10.3389/fmed.2020.00210. eCollection 2020.
- Lu Y, Li Y, Deng W, Liu M, He Y, Huang L, Lv M, Li J, Du H. Symptomatic Infection is Associated with Prolonged Duration of Viral Shedding in Mild Coronavirus Disease 2019: A Retrospective Study of 110 Children in Wuhan. Pediatr Infect Dis J. 2020 Jul;39(7):e95-e99. doi: 10.1097/INF.0000000000002729.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年6月1日
一次修了 (実際)
2020年7月15日
研究の完了 (実際)
2020年7月15日
試験登録日
最初に提出
2020年9月12日
QC基準を満たした最初の提出物
2020年9月17日
最初の投稿 (実際)
2020年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月22日
QC基準を満たした最後の更新が送信されました
2020年9月19日
最終確認日
2020年9月1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
- 1004
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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