Evaluating Clinical Parameters of COVID-19 in Pregnancy (COpregVID)
9 oktober 2020 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
116
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Research Delivery Operations Manager
- Telefonnummer: 020 3315 6825
- E-post: research.development@chewest.nhs.uk
Studera Kontakt Backup
- Namn: Natasha Singh, MRCOG, MD
- E-post: Natasha.Singh@chelwest.nhs.uk
Studieorter
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London, Storbritannien, SW10 9NH
- Rekrytering
- Chelsea And Westminster Hospital
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Kontakt:
- Natasha Singh
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Huvudutredare:
- Nishel Shah, MRCOG, PhD
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London, Storbritannien, SW10 9NH
- Rekrytering
- Chelsea And Westminster Hospital NHS Foundation Trust
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Kontakt:
- Natasha Singh, MRCOG; MD
- E-post: Natasha.Singh@chelwest.nhs.uk
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Huvudutredare:
- Nishel Shah
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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. |
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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.
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.
Tidsram: 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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Nishel Shah, MRCOG, PhD, Chelsea And Westminster Hospital NHS Foundation Trust
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Användbara länkar
- 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 oktober 2020
Primärt slutförande (Förväntat)
1 november 2021
Avslutad studie (Förväntat)
2 december 2021
Studieregistreringsdatum
Först inskickad
13 juli 2020
Först inskickad som uppfyllde QC-kriterierna
13 juli 2020
Första postat (Faktisk)
14 juli 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C&W20/034
- 283995 (Annan identifierare: Integrated Research Application System (IRAS))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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