Hydroxy Chloroquine and Covid in RA Patients (Covid-19)
Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study
調査の概要
状態
条件
詳細な説明
Study settings & sample:
This is an observational, retrospective -case-control, single-center study. This study will include patients who meet the inclusion criteria followed in the Department of Rheumatology and Rehabilitation, Tanta University Hospital, Tanta, Egypt.
Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. All patients will sign the informed consent form authorizing the collection of these data.
Group classification A) Patients with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
b) Patients with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.
Data will be collected and analyzed from patient medical records. It will include the following:
- Epidemiologic, demographic, and clinical data.
- Severity of rheumatoid arthritis.
- Rheumatoid arthritis activity state using the Clinical Disease Activity Index
- Dose and duration of hydroxychloroquine
- Need for hospitalization, length of hospital stay, and ICU admission including the need for mechanical ventilation.
- Duration from the start of symptoms until clinical cure.
- Severity of COVID-19 disease according to the World Health Organization interim guidance
- Prognosis.
Laboratory investigations and imaging:
- Complete blood count.
- Renal and liver function tests.
- Random blood sugar.
- Lactate dehydrogenase, D-dimer.
- Serum ferritin, C-reactive protein,
- Chest radiographs or CT scan
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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Tanta、エジプト、31527
- 募集
- Tanta University Hospital
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コンタクト:
- Mohammed Hassan Abu-Zaid, PhD
- 電話番号:+201006773622
- メール:drmhassan113@yahoo.com
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コンタクト:
- Samar A Tabra, PhD
- 電話番号:+201007501572
- メール:dr_stabra_113@yahoo.com
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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
To Evaluaye the clinical course of COVID-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine:
Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation department, Tanta University hospital, Tanta, Egypt.
A) Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
b) Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.
Primary Outcome Measures:
1. Impact of hydroxychloroquine on the clinical course of Covid-19 in the hydroxychloroquine group compared to the non- hydroxychloroquine group.
Data will be collected and analyzed from patient medical records.
説明
Inclusion Criteria:
- Adult patients with rheumatoid arthritis superinfected with Covid-19
Exclusion Criteria:
- Insufficient data are available in the medical record.
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:ケースコントロール
- 時間の展望:回顧
コホートと介入
グループ/コホート |
|---|
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Experimental
Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
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Active Comparator
Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen
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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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Number of patients in need for hospitalization
時間枠:through study completion an average 12 weeks
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Estimate number of patients in need for hospitalization
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through study completion an average 12 weeks
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Length of hospitalization and ICU admission
時間枠:through study completion an average 12 weeks
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Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU
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through study completion an average 12 weeks
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The need for mechanical ventilation
時間枠:through study completion an average 12 weeks
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Calculate the number of patients who received mechanical ventilation
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through study completion an average 12 weeks
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Severity of COVID-19 disease
時間枠:through study completion an average 12 weeks
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WHO clinical management Covid19 interim guidance disease severity Algorithm
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through study completion an average 12 weeks
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Asem Elfert, Prof、Tanta University Faculty of Medicine
出版物と役立つリンク
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
キーワード
その他の研究ID番号
- 002 (University of CT Health Center)
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?
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。