Evaluating Clinical Parameters of COVID-19 in Pregnancy

NCT04470583 | Unknown

• 2 other identifiers: C&W20/034283995
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COVID-19; 2019 Novel Coronavirus Infection; COVID-19 Infection

Keywords

COVID-19; Pregnancy; Retrospective case review

Outcome Measures

Primary Outcomes (2)

• Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.

  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.

  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.

Secondary Outcomes (1)

• 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.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• COVID-19 infection
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (2)

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

RECRUITING

Related Publications (34)

• 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.

  PMID: 31978945 BACKGROUND

• 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.

  PMID: 27012512 BACKGROUND

• 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.

  PMID: 19892230 BACKGROUND

• Masters PS. The molecular biology of coronaviruses. Adv Virus Res. 2006;66:193-292. doi: 10.1016/S0065-3527(06)66005-3.

  PMID: 16877062 BACKGROUND

• 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.

  PMID: 15034574 BACKGROUND

• 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.

  PMID: 32125418 BACKGROUND

• 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.

  PMID: 32234451 BACKGROUND

• 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.

  PMID: 16019455 BACKGROUND

• 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.

  PMID: 12837163 BACKGROUND

• 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.

  PMID: 12816821 BACKGROUND

• 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.

  PMID: 32178975 BACKGROUND

• 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.

  PMID: 32296910 BACKGROUND

• 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.

  PMID: 32330308 BACKGROUND

• 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.

  PMID: 32073213 BACKGROUND

• 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.

  PMID: 32296069 BACKGROUND

• 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.

  PMID: 32129508 BACKGROUND

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 32203186 BACKGROUND

• 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.

  PMID: 32320677 BACKGROUND

• 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.

  PMID: 32265517 BACKGROUND

• 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.

  PMID: 15295381 BACKGROUND

• LoMauro A, Aliverti A. Respiratory physiology of pregnancy: Physiology masterclass. Breathe (Sheff). 2015 Dec;11(4):297-301. doi: 10.1183/20734735.008615.

  PMID: 27066123 BACKGROUND

• 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.

  PMID: 29044422 BACKGROUND

• 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.

  PMID: 32050635 BACKGROUND

• 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.

  PMID: 25254368 BACKGROUND

• 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.

  PMID: 32269088 BACKGROUND

• 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.

  PMID: 32633729 BACKGROUND

• ICNARC report on COVID-19 in critical care London, UK: Intensive Care National Audit & Research Centre (ICNARC); 2020 04 April 2020.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32311650 BACKGROUND

• 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.

  PMID: 32105632 BACKGROUND

• Greer O, Shah NM, Johnson MR. Maternal sepsis update: current management and controversies. The Obstetrician & Gynaecologist. 2020;22(1):45-55.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 3928249 BACKGROUND

Related 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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nishel Shah, MRCOG, PhD

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Delivery Operations Manager

CONTACT

020 3315 6825; research.development@chewest.nhs.uk

Natasha Singh, MRCOG, MD

CONTACT

Natasha.Singh@chelwest.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 14, 2020
• Study Start: October 9, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 2, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)