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

9. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

116

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • London, Storbritannia, SW10 9NH
        • Rekruttering
        • Chelsea and Westminster Hospital
        • Ta kontakt med:
          • Natasha Singh
        • Hovedetterforsker:
          • Nishel Shah, MRCOG, PhD
      • London, Storbritannia, SW10 9NH
        • Rekruttering
        • Chelsea and Westminster Hospital NHS Foundation Trust
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nishel Shah

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.
Tidsramme: 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.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. oktober 2020

Primær fullføring (Forventet)

1. november 2021

Studiet fullført (Forventet)

2. desember 2021

Datoer for studieregistrering

Først innsendt

13. juli 2020

Først innsendt som oppfylte QC-kriteriene

13. juli 2020

Først lagt ut (Faktiske)

14. juli 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C&W20/034
  • 283995 (Annen identifikator: Integrated Research Application System (IRAS))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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