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Evaluating Clinical Parameters of COVID-19 in Pregnancy (COpregVID)

2020년 10월 9일 업데이트: Chelsea and Westminster NHS Foundation Trust

Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)

Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.

연구 개요

상태

알려지지 않은

정황

상세 설명

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.

연구 유형

관찰

등록 (예상)

116

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 영국
      • London, 영국, SW10 9NH
        • 모병
        • Chelsea and Westminster Hospital
        • 연락하다:
          • Natasha Singh
        • 수석 연구원:
          • Nishel Shah, MRCOG, PhD
      • London, 영국, SW10 9NH
        • 모병
        • Chelsea and Westminster Hospital NHS Foundation Trust
        • 연락하다:
        • 수석 연구원:
          • Nishel Shah

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Due to the novel nature of this project, patients will not be stratified for specific demographic differences such as age, ethnicity or BMI. As there is very little data on SARS or COVID-19 infection in pregnant and postnatal women within 6 weeks of birth, power calculations used data from non-pregnant cases. In our institution so far, we have had 17 pregnant or postnatal women with COVID-19, and approximately 5 non-pregnant women of childbearing age out of a total of 273 cases (as of 1nd May 2020). Therefore, for some of non-pregnant data collection, we will be using data obtained from both male and female participants with a wider age range than our pregnant and postnatal group. Once all the data has been collected, we may stratify them based on age, gender, BMI, and ethnicity.

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.
기간: From the start of the study up until one month prior to study end.
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.
From the start of the study up until one month prior to study end.
Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.
기간: From the start of the study up until one month prior to study end.
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.
From the start of the study up until one month prior to study end.

2차 결과 측정

결과 측정
측정값 설명
기간
Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
기간: From the start of the study up until one month prior to study end.
Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
From the start of the study up until one month prior to study end.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chelsea and Westminster NHS Foundation Trust

수사관

  • 수석 연구원: Nishel Shah, MRCOG, PhD, Chelsea and Westminster Hospital NHS Foundation Trust

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 10월 9일

기본 완료 (예상)

2021년 11월 1일

연구 완료 (예상)

2021년 12월 2일

연구 등록 날짜

최초 제출

2020년 7월 13일

QC 기준을 충족하는 최초 제출

2020년 7월 13일

처음 게시됨 (실제)

2020년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 10월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 10월 9일

마지막으로 확인됨

2020년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • C&W20/034
  • 283995 (기타 식별자: Integrated Research Application System (IRAS))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Research team wishes to enable any meta-analyses of COVID-19 trials making appropriate requests. No plan to share IPD has been made at this time.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

코로나바이러스감염증-19 : 코로나19에 대한 임상 시험

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정황

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약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다