Evaluating Clinical Parameters of COVID-19 in Pregnancy (COpregVID)
9. oktober 2020 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
116
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Research Delivery Operations Manager
- Telefonnummer: 020 3315 6825
- E-mail: research.development@chewest.nhs.uk
Undersøgelse Kontakt Backup
- Navn: Natasha Singh, MRCOG, MD
- E-mail: Natasha.Singh@chelwest.nhs.uk
Studiesteder
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London, Det Forenede Kongerige, SW10 9NH
- Rekruttering
- Chelsea And Westminster Hospital
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Kontakt:
- Natasha Singh
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Ledende efterforsker:
- Nishel Shah, MRCOG, PhD
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London, Det Forenede Kongerige, SW10 9NH
- Rekruttering
- Chelsea And Westminster Hospital NHS Foundation Trust
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Kontakt:
- Natasha Singh, MRCOG; MD
- E-mail: Natasha.Singh@chelwest.nhs.uk
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Ledende efterforsker:
- Nishel Shah
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Nishel Shah, MRCOG, PhD, Chelsea And Westminster Hospital NHS Foundation Trust
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Wevers BA, van der Hoek L. Recently discovered human coronaviruses. Clin Lab Med. 2009 Dec;29(4):715-24. doi: 10.1016/j.cll.2009.07.007.
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- Petrosillo N, Viceconte G, Ergonul O, Ippolito G, Petersen E. COVID-19, SARS and MERS: are they closely related? Clin Microbiol Infect. 2020 Jun;26(6):729-734. doi: 10.1016/j.cmi.2020.03.026. Epub 2020 Mar 28.
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- Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, Damoraki G, Gkavogianni T, Adami ME, Katsaounou P, Ntaganou M, Kyriakopoulou M, Dimopoulos G, Koutsodimitropoulos I, Velissaris D, Koufargyris P, Karageorgos A, Katrini K, Lekakis V, Lupse M, Kotsaki A, Renieris G, Theodoulou D, Panou V, Koukaki E, Koulouris N, Gogos C, Koutsoukou A. Complex Immune Dysregulation in COVID-19 Patients with Severe Respiratory Failure. Cell Host Microbe. 2020 Jun 10;27(6):992-1000.e3. doi: 10.1016/j.chom.2020.04.009. Epub 2020 Apr 21.
- Kong WH, Li Y, Peng MW, Kong DG, Yang XB, Wang L, Liu MQ. SARS-CoV-2 detection in patients with influenza-like illness. Nat Microbiol. 2020 May;5(5):675-678. doi: 10.1038/s41564-020-0713-1. Epub 2020 Apr 7.
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- Wong SF, Chow KM, Leung TN, Ng WF, Ng TK, Shek CC, Ng PC, Lam PW, Ho LC, To WW, Lai ST, Yan WW, Tan PY. Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol. 2004 Jul;191(1):292-7. doi: 10.1016/j.ajog.2003.11.019.
- Masters PS. The molecular biology of coronaviruses. Adv Virus Res. 2006;66:193-292. doi: 10.1016/S0065-3527(06)66005-3.
- Yang M, Ng MH, Li CK. Thrombocytopenia in patients with severe acute respiratory syndrome (review). Hematology. 2005 Apr;10(2):101-5. doi: 10.1080/10245330400026170.
- He WQ, Chen SB, Liu XQ, Li YM, Xiao ZL, Zhong NS. [Death risk factors of severe acute respiratory syndrome with acute respiratory distress syndrome]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2003 Jun;15(6):336-7. Chinese.
- Lippi G, Plebani M, Henry BM. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020 Jul;506:145-148. doi: 10.1016/j.cca.2020.03.022. Epub 2020 Mar 13.
- Xu P, Zhou Q, Xu J. Mechanism of thrombocytopenia in COVID-19 patients. Ann Hematol. 2020 Jun;99(6):1205-1208. doi: 10.1007/s00277-020-04019-0. Epub 2020 Apr 15.
- Fogarty H, Townsend L, Ni Cheallaigh C, Bergin C, Martin-Loeches I, Browne P, Bacon CL, Gaule R, Gillett A, Byrne M, Ryan K, O'Connell N, O'Sullivan JM, Conlon N, O'Donnell JS. COVID19 coagulopathy in Caucasian patients. Br J Haematol. 2020 Jun;189(6):1044-1049. doi: 10.1111/bjh.16749. Epub 2020 May 17.
- Fan BE, Chong VCL, Chan SSW, Lim GH, Lim KGE, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. Am J Hematol. 2020 Jun;95(6):E131-E134. doi: 10.1002/ajh.25774. Epub 2020 Mar 19. No abstract available. Erratum In: Am J Hematol. 2020 Nov;95(11):1442.
- Zheng HY, Zhang M, Yang CX, Zhang N, Wang XC, Yang XP, Dong XQ, Zheng YT. Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):541-543. doi: 10.1038/s41423-020-0401-3. Epub 2020 Mar 17. No abstract available.
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- Schwartz DA, Graham AL. Potential Maternal and Infant Outcomes from (Wuhan) Coronavirus 2019-nCoV Infecting Pregnant Women: Lessons from SARS, MERS, and Other Human Coronavirus Infections. Viruses. 2020 Feb 10;12(2):194. doi: 10.3390/v12020194.
- Cerbulo-Vazquez A, Figueroa-Damian R, Arriaga-Pizano LA, Hernandez-Andrade E, Mancilla-Herrera I, Flores-Mejia LA, Arteaga-Troncoso G, Lopez-Macias C, Isibasi A, Mancilla-Ramirez J. Pregnant women infected with pandemic H1N1pdm2009 influenza virus displayed overproduction of peripheral blood CD69+ lymphocytes and increased levels of serum cytokines. PLoS One. 2014 Sep 25;9(9):e107900. doi: 10.1371/journal.pone.0107900. eCollection 2014.
- Du RH, Liang LR, Yang CQ, Wang W, Cao TZ, Li M, Guo GY, Du J, Zheng CL, Zhu Q, Hu M, Li XY, Peng P, Shi HZ. Predictors of mortality for patients with COVID-19 pneumonia caused by SARS-CoV-2: a prospective cohort study. Eur Respir J. 2020 May 7;55(5):2000524. doi: 10.1183/13993003.00524-2020. Print 2020 May. Erratum In: Eur Respir J. 2020 Sep 24;56(3):
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Hjælpsomme links
- 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. oktober 2020
Primær færdiggørelse (Forventet)
1. november 2021
Studieafslutning (Forventet)
2. december 2021
Datoer for studieregistrering
Først indsendt
13. juli 2020
Først indsendt, der opfyldte QC-kriterier
13. juli 2020
Først opslået (Faktiske)
14. juli 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C&W20/034
- 283995 (Anden identifikator: Integrated Research Application System (IRAS))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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