Evaluating Clinical Parameters of COVID-19 in Pregnancy
NCT ID: NCT04470583
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
116 participants
OBSERVATIONAL
2020-10-09
2021-12-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic
NCT04360811
Prevalence and Impact of COVID-19 Infection in Pregnant Women, Fetuses and Newborns
NCT04355234
Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic
NCT04388605
Characteristics of COVID-19 Infection Among PREGnant Women
NCT04398264
COPE - COVID-19 in Pregnancy and Early Childhood
NCT04433364
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nishel Shah, MRCOG, PhD
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Natasha Singh
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
Su S, Wong G, Shi W, Liu J, Lai ACK, Zhou J, Liu W, Bi Y, Gao GF. Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502. doi: 10.1016/j.tim.2016.03.003. Epub 2016 Mar 21.
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.
Masters PS. The molecular biology of coronaviruses. Adv Virus Res. 2006;66:193-292. doi: 10.1016/S0065-3527(06)66005-3.
van der Hoek L, Pyrc K, Jebbink MF, Vermeulen-Oost W, Berkhout RJ, Wolthers KC, Wertheim-van Dillen PM, Kaandorp J, Spaargaren J, Berkhout B. Identification of a new human coronavirus. Nat Med. 2004 Apr;10(4):368-73. doi: 10.1038/nm1024. Epub 2004 Mar 21.
Sahu KK, Mishra AK, Lal A. Coronavirus disease-2019: An update on third coronavirus outbreak of 21st century. QJM. 2020 May 1;113(5):384-386. doi: 10.1093/qjmed/hcaa081. No abstract available.
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.
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.
Wong RS, Wu A, To KF, Lee N, Lam CW, Wong CK, Chan PK, Ng MH, Yu LM, Hui DS, Tam JS, Cheng G, Sung JJ. Haematological manifestations in patients with severe acute respiratory syndrome: retrospective analysis. BMJ. 2003 Jun 21;326(7403):1358-62. doi: 10.1136/bmj.326.7403.1358.
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.
Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
Tan L, Wang Q, Zhang D, Ding J, Huang Q, Tang YQ, Wang Q, Miao H. Lymphopenia predicts disease severity of COVID-19: a descriptive and predictive study. Signal Transduct Target Ther. 2020 Mar 27;5(1):33. doi: 10.1038/s41392-020-0148-4. No abstract available.
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.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
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.
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.
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.
LoMauro A, Aliverti A. Respiratory physiology of pregnancy: Physiology masterclass. Breathe (Sheff). 2015 Dec;11(4):297-301. doi: 10.1183/20734735.008615.
Zollner J, Howe LG, Edey LF, O'Dea KP, Takata M, Gordon F, Leiper J, Johnson MR. The response of the innate immune and cardiovascular systems to LPS in pregnant and nonpregnant mice. Biol Reprod. 2017 Aug 1;97(2):258-272. doi: 10.1093/biolre/iox076.
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.
Han Y, Zhang H, Mu S, Wei W, Jin C, Tong C, Song Z, Zha Y, Xue Y, Gu G. Lactate dehydrogenase, an independent risk factor of severe COVID-19 patients: a retrospective and observational study. Aging (Albany NY). 2020 Jun 24;12(12):11245-11258. doi: 10.18632/aging.103372. Epub 2020 Jun 24.
ICNARC report on COVID-19 in critical care London, UK: Intensive Care National Audit & Research Centre (ICNARC); 2020 04 April 2020.
Bouch, D. C., & Thompson, J. P. (2008). Severity scoring systems in the critically ill. Continuing Education in Anaesthesia Critical Care & Pain, 8(5), 181-185. https://doi.org/10.1093/bjaceaccp/mkn033
Zhang G, Hu C, Luo L, Fang F, Chen Y, Li J, Peng Z, Pan H. Clinical features and short-term outcomes of 221 patients with COVID-19 in Wuhan, China. J Clin Virol. 2020 Jun;127:104364. doi: 10.1016/j.jcv.2020.104364. Epub 2020 Apr 9.
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
Greer O, Shah NM, Johnson MR. Maternal sepsis update: current management and controversies. The Obstetrician & Gynaecologist. 2020;22(1):45-55.
Zheng Y, Huang Z, Ying G, Zhang X, Ye W, Hu Z, et al. Study of the lymphocyte change between COVID-19 and non-COVID-19 pneumonia cases suggesting other factors besides uncontrolled inflammation contributed to multi-organ injury. medRxiv. 2020:2020.02.19.20024885.
Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
283995
Identifier Type: OTHER
Identifier Source: secondary_id
C&W20/034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.