Evaluating Clinical Parameters of COVID-19 in Pregnancy (COpregVID)
Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)
調査の概要
状態
詳細な説明
This study will be a retrospective case review using existing clinical data from participating centres. To date there have already been 18,000 confirmed cases in Greater London. Our study design will aim to include patients who were diagnosed with COVID-19 at the start of the pandemic as well as new and current cases.
The study design requires data to be extracted from National Health Service (NHS) electronic and paper notes, which will contain patient identifiable information. For confidentiality, all patient identifiable data will only be collected by members of the direct care team. This data will be encrypted and stored in a local NHS trust computer at participating sites. In order to maintain confidentiality, all data will then be anonymised before being inputted on a data collection tool and spreadsheet. Therefore, research teams will only be provided with a de-identified dataset. This data will be transferred across to the study co-ordination centre, following NHS information governance rules for data to be compiled and analysed. At the co-ordination centre, this data will be stored in an Imperial College London computer, and will only be accessible to the research team.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Research Delivery Operations Manager
- 電話番号:020 3315 6825
- メール:research.development@chewest.nhs.uk
研究連絡先のバックアップ
- 名前:Natasha Singh, MRCOG, MD
- メール:Natasha.Singh@chelwest.nhs.uk
研究場所
-
-
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London、イギリス、SW10 9NH
- 募集
- Chelsea And Westminster Hospital
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コンタクト:
- Natasha Singh
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主任研究者:
- Nishel Shah, MRCOG, PhD
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London、イギリス、SW10 9NH
- 募集
- Chelsea And Westminster Hospital NHS Foundation Trust
-
コンタクト:
- Natasha Singh, MRCOG; MD
- メール:Natasha.Singh@chelwest.nhs.uk
-
主任研究者:
- Nishel Shah
-
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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
説明
Inclusion Criteria:
- COVID-19 infection
- 18-50 years for Groups A and B and 18-60 years for Groups C and D
- Female for groups A and B. Both male and female for groups C and D.
Exclusion Criteria:
- Participants who have previously been part of a SARS-CoV-2 vaccine trial.
- Current hospital admission due to another respiratory disease, such as influenza.
- Obvious clinical deterioration due to another medical problem such as cardiovascular disease, diabetes or malignancy.
- Evidence of HIV infection and/or participants on anti-retroviral drug therapy.
- Participants on chemotherapy, biologics, immune-modulators or immunosuppressive drugs (not including intramuscular steroids for fetal lung maturity).
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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Mild/moderate COVID-19 affected pregnant and postnatal women
Pregnant and postnatal women who contracted COVID-19 and recovered without the need for ventilation will be classified as mild to moderate.
Participants will be aged between 18-50 years old.
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Severe/Critical COVID-19 affected pregnant and postnatal women
Pregnant and postnatal women who are admitted to hospital after contracting COVID-19 and received ventilatory support before recovering will be classified as severe to critical. Participants will be aged between 18-50 years old. These participants will be identified from Intensive Treatment Unit (ITU), and standard COVID-19 wards. |
Mild/moderate COVID-19 affected non-pregnant participants
Both male and non-pregnant female participants who contracted COVID-19 and recovered without the need for ventilation will be classified as mild to moderate.
Participants will be aged between 18-60 years old.
|
Severe/Critical COVID-19 affected non-pregnant participants
Both male and non-pregnant female participants who are admitted to hospital after contracting COVID-19 and received ventilatory support before recovering will be classified as severe to critical.
Participants will be aged between 18-60 years old.
These participants will be identified from Intensive Treatment Unit (ITU), and standard COVID-19 wards.
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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 |
---|---|---|
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.
時間枠:From the start of the study up until one month prior to study end.
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Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.
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From the start of the study up until one month prior to study end.
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Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.
時間枠:From the start of the study up until one month prior to study end.
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Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.
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From the start of the study up until one month prior to study end.
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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 |
---|---|---|
Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
時間枠:From the start of the study up until one month prior to study end.
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Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
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From the start of the study up until one month prior to study end.
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協力者と研究者
捜査官
- 主任研究者:Nishel Shah, MRCOG, PhD、Chelsea And Westminster Hospital NHS Foundation Trust
出版物と役立つリンク
一般刊行物
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便利なリンク
- The World Health Organisation's advice and guidance on the coronavirus disease (COVID-19) pandemic
- The UK Government's report on the number of coronavirus (COVID-19) cases and risk in the UK
- The economic consequences of Covid-19 ' an article by Iain Begg, Professor at the London School of Economics and Political Science
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
- C&W20/034
- 283995 (その他の識別子:Integrated Research Application System (IRAS))
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?
IPD プランの説明
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。
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