COVID-19COpregVIDNCT04470583
Evaluating Clinical Parameters of COVID-19 in Pregnancy
An observational study of COVID-19 and 2019 Novel Coronavirus Infection, run by Chelsea and Westminster NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, 2019 Novel Coronavirus Infection, COVID-19 Infection
- How many people
- 116 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 Oct 2020to 2 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Natasha Singh, MRCOG, MD contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Research Delivery Operations Manager, 020 3315 6825, research.development@chelwest.nhs.uk
Natasha Singh, MRCOG; MD, Natasha.Singh@chelwest.nhs.uk
- Recruiting
Chelsea and Westminster Hospital
London, SW10 9NH
Research Delivery Operations Manager, 020 3315 6825, research.development@chelwest.nhs.uk
Natasha Singh
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- COVID-19, Pregnancy, Retrospective case review
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Measured: From the start of the study up until one month prior to study end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start9 Oct 2020
- Primary completionNov 2021 (estimated)
- Study completion2 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nishel Shah, MRCOG, PhD, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470583
- Sponsor's protocol ID
- C&W20/034
- Other IDs
- 283995
- Acronym
- COpregVID
- Status last verified
- Oct 2020
- First submitted
- 13 Jul 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31978945Su 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.
PubMed 27012512Wevers 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.
PubMed 19892230Masters PS. The molecular biology of coronaviruses. Adv Virus Res. 2006;66:193-292. doi: 10.1016/S0065-3527(06)66005-3.
PubMed 16877062van 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.
PubMed 15034574Sahu 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.
PubMed 32125418Petrosillo 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.
PubMed 32234451Yang 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.
PubMed 16019455He 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.
PubMed 12837163Wong 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.
PubMed 12816821Lippi 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.
PubMed 32178975Xu 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.
PubMed 32296910Fogarty 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.
PubMed 32330308Tang 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.
PubMed 32073213Tan 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.
PubMed 32296069
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)
- ClinicalTrials.gov ID
- NCT04470583
- Acronym / sponsor ID
- COpregVID / C&W20/034
- Keywords
- COVID-19, Pregnancy, Retrospective case review
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- 2 Dec 2021 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.
Time frame: From the start of the study up until one month prior to study end.
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.
Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.
Time frame: From the start of the study up until one month prior to study end.
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.
1 secondary outcome
Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Time frame: From the start of the study up until one month prior to study end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 27012512Su 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.
- Background: PubMed 19892230Wevers 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.
- Background: PubMed 16877062Masters PS. The molecular biology of coronaviruses. Adv Virus Res. 2006;66:193-292. doi: 10.1016/S0065-3527(06)66005-3.
- Background: PubMed 15034574van 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.
- Background: PubMed 32125418Sahu 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.
- Background: PubMed 32234451Petrosillo 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.
- Background: PubMed 16019455Yang 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.
- Background: PubMed 12837163He 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.
- Background: PubMed 12816821Wong 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.
- Background: PubMed 32178975Lippi 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.
- Background: PubMed 32296910Xu 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.
- The World Health Organisation's advice and guidance on the coronavirus disease (COVID-19) pandemicLink provided by the sponsor.
- The UK Government's report on the number of coronavirus (COVID-19) cases and risk in the UKLink provided by the sponsor.
- The economic consequences of Covid-19 ' an article by Iain Begg, Professor at the London School of Economics and Political ScienceLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Singh, MRCOG, MD contact
Nishel Shah, MRCOG, PhD principal investigator
Chelsea and Westminster NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and 2019 Novel Coronavirus Infection, run by Chelsea and Westminster NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Delivery Operations Manager (020 3315 6825, research.development@chewest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women. (time frame: From the start of the study up until one month prior to study end.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470583, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.