Evaluating Clinical Parameters of COVID-19 in Pregnancy (COpregVID)
2020. október 9. frissítette: 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.
A tanulmány áttekintése
Állapot
Ismeretlen
Körülmények
Részletes leírás
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.
Tanulmány típusa
Megfigyelő
Beiratkozás (Várható)
116
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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London, Egyesült Királyság, SW10 9NH
- Toborzás
- Chelsea and Westminster Hospital
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Kapcsolatba lépni:
- Natasha Singh
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Kutatásvezető:
- Nishel Shah, MRCOG, PhD
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London, Egyesült Királyság, SW10 9NH
- Toborzás
- Chelsea and Westminster Hospital NHS Foundation Trust
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Kapcsolatba lépni:
- Natasha Singh, MRCOG; MD
- E-mail: Natasha.Singh@chelwest.nhs.uk
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Kutatásvezető:
- Nishel Shah
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
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.
Leírás
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).
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.
Időkeret: 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.
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Kutatásvezető: Nishel Shah, MRCOG, PhD, Chelsea and Westminster Hospital NHS Foundation Trust
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
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Hasznos linkek
- 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
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2020. október 9.
Elsődleges befejezés (Várható)
2021. november 1.
A tanulmány befejezése (Várható)
2021. december 2.
Tanulmányi regisztráció dátumai
Először benyújtva
2020. július 13.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2020. július 13.
Első közzététel (Tényleges)
2020. július 14.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. október 12.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. október 9.
Utolsó ellenőrzés
2020. október 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- C&W20/034
- 283995 (Egyéb azonosító: Integrated Research Application System (IRAS))
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
IPD terv leírása
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.
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Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .