Condition category
Infections and Infestations
Date applied
12/05/2020
Date assigned
11/06/2020
Last edited
11/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
Several expert groups, including the Royal College of Obstetricians and Gynaecologists have suggested pregnant women, who are usually young and healthy, are at increased risk of becoming unwell if they catch the virus. There is very limited information for healthcare professionals on how to best treat women who become unwell. Pregnant women and their families are understandably worried because little is known about how infection progresses. Researchers have proposed to carry out a research study to answer the following about pregnant women diagnosed with COVID-19:
1. What are the factors that might make pregnant women more prone to severe infection? The researchers are especially interested in the impact of ethnicity.
2. What happens to the system that the body uses to fight infections (known as the immune system) of pregnant women who are admitted to hospital?
3. Is there any immune response against the virus in the placenta?
4. What are the short and medium to long-term implications to women who develop COVID-19 infection in pregnancy and their babies?
It is hoped that answering these questions will improve the care given to pregnant women in East London and across the UK.

Who can participate?
Pregnant women who are admitted to a Barts Health NHS Trust hospital and have suspected (symptomatic) or confirmed COVID-19 infection and up to 2 weeks post-delivery. They must be 18 years or older. Pregnant women may also be identified via the COVIDENCE-UK study, a national study of individuals enrolled from the community who are potentially diagnosed with COVID-19.

What does the study involve?
A sample of blood will be taken to examine the immune cells in the participant’s blood and a sample of their urine to check the health of their kidneys. This will mean taking a little extra blood (5 ml, about a teaspoon) when the routine blood test is taken. Comparing these immune cells between different women can help us understand why some women get sicker than others. The researchers will also run some standard laboratory tests on the participant’s blood to measure the level of infection. They will collect routine data from the participant’s hospital or GP records, such as standard information about their pregnancy, the outcome of their birth, their health and the health of their baby. After the participant has given birth, the researchers would like to collect the placenta (afterbirth) of a sub-set of women and a little blood from the cord, to examine whether the virus is present or whether there is an immune response in the placenta, and whether protective antibodies are passed on to their baby. If the participant does not wish the researchers to collect this, the participant can still take part in the rest of the study. The researchers will invite participants for up to three hospital visits, 3, 6 and 12 months after they have had their baby. This is to test their lung function (this involves blowing hard into a machine to measure the capacity of their lungs), and to ask them questions about their health. The researchers will also take another blood sample (10 ml, about 2 teaspoons) at these visits to examine their immune response again, as well as a small amount of urine. If the participant is unable to come to the hospital, the researchers will call them instead, but they will get a better picture of how healthy the participant’s lungs are if they come into the hospital for this visit.

What are the possible benefits and risks of participating?
Although participants may not receive any direct benefits from participating in the study, they will be able to contribute to the advancement of understanding of the effects of COVID 19 on medium- to long-term maternal lung function and immunological response in pregnant women and their babies. As there is no intervention for this study it is anticipated that the risk to participants’ physical wellbeing associated with participation in this study are low.

Where is the study run from?
The study is coordinated from the Centre for Women’s Health, Queen Mary University of London. The study is recruiting at Barts Health NHS Trust.

When is the study starting and how long is it expected to run for?
May 2020 to June 2022

Who is funding the study?
The study has received initial funding from the February Foundation and is currently subject to further funding applications to enable full participant follow-up.

Who is the main contact?
Dr Stamatina Iliodromiti (clinical)
Dr Julie Dodds (operational)
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.

Trial website

https://www.barc-research.org/covipreg

Contact information

Type

Public

Primary contact

Dr Julie Dodds

ORCID ID

http://orcid.org/0000-0002-6041-1456

Contact details

Centre for Women's Health Research
Institute of Population Health Sciences
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom

Type

Scientific

Additional contact

Dr Stamatina Iliodromiti

ORCID ID

http://orcid.org/0000-0001-6453-6654

Contact details

Centre for Women's Health Research
Institute of Population Health Sciences
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 283699

Study information

Scientific title

COVID-19 infection in pregnancy (COVIpreg-UK): a prospective cohort study of immunological response and long-term maternal morbidity

Acronym

COVIpreg-UK

Study hypothesis

COVID-19 is a novel disease which has triggered unanswered questions, many related to its progression and sequelae of events in pregnancy. The researchers propose a prospective cohort study of pregnant women admitted to Barts Health NHS Trust with confirmed or suspected COVID-19 to allow systematic categorisation of women according to clinical and immune phenotypes.

Ethics approval

Approved 19/05/2020, North West – Haydock Research Ethics Committee (3rd Floor – Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048012; haydock.rec@hra.nhs.uk), REC ref: 20/NW/0257

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection) in pregnant women

Intervention

This study is designed as a prospective cohort study of pregnant women admitted to hospital with suspected or confirmed COVID-19 infection who consent to participation in the study. Recruitment will be over 6 months with follow-up data being collected at 3, 6 and 12 months post-discharge, or post-delivery (if COVID-19 infection does not coincide with delivery time). There will be an additional blood sample for immunological response assessments. Follow up data include lung function tests (spirometry) and exercise capacity assessments (6-minute walk). Quality of life questionnaire (EQ-5D-3L). Tissue from the placenta and cord blood will be taken on a subset of women.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Lung function for mothers measured by spirometry at 3 months post-discharge (if COVID-19 infection coincides with delivery) or 3 months post-delivery (if COVID-19 infection does not result in or coincide with delivery)

Secondary outcome measures

Maternal outcome measures:
1. Lung function: Forced Expiratory Volume in one second (FEV1 measured in Litres); Forced Vital Capacity (FVC measured in Litres); Forced Expiratory Flow between 25% and 75% of vital capacity (FEF25-75 measured in Litres/sec) measured using NDD Easy on-PC spirometer and weight (for adjustment of lung function test) for mothers at 3, 6 and 12 months post-discharge, or post-delivery (in the event that admission for COVID-19 infection does not coincide with delivery)
2. A 6-minute walking test measuring how far in metres the participant can walk in 6 minutes, collected at 3, 6 and 12 months post-discharge or post-delivery
3. Breathlessness measured using a short MRC dyspnoea scale questionnaire, scored from 1 (best) to 5 (worst), collected at 3, 6 and 12 month follow up visits
4. Clinical information related to COVID-19 infection (symptoms, treatment and date of diagnosis) at baseline and delivery
5. Laboratory assessments (Protein to Creatinine Ratio in urine, Full blood count [FBC], Urea and Electrolytes [U&Es], LDH, Liver function tests [LFTs], D-Dimer, C-Reactive Protein [CRP]) at baseline, 3, 6 and 12 months post-discharge or post-delivery
6. Radiological findings on chest X-ray or CT chest (when clinically indicated) at baseline
7. Immunological profile measured using flow cytometry and qPCR at baseline, 3, 6 and 12 months post-discharge or post-delivery
8. Thromboembolic events collected from medical records during admission or within 6 weeks of delivery
9. Quality of life measured using EQ-5D-3L Questionnaire at 3, 6 and 12 months post-discharge or post-delivery

At discharge (collected from medical records):
10. Length of hospital stay
11. Reason for admission
12. Admission to intensive care/high dependency unit
13. Time to admission to intensive care/high dependency unit from admission
14. Type of respiratory support

At discharge, 3, 6 and 12 months post-discharge, or post-delivery (collected from medical records):
15. All-cause mortality
16. Time to death

Obstetric outcome measures:
At delivery (collected from medical records):
17. Mode of delivery
18. Gestation of delivery
19. Blood loss at delivery/transfusion at delivery
20. Mode of anaesthesia
21. Operative interventions (any reason)
22. Placental histology and microscopy (on a subset of women)

Infant outcome measures:
At delivery (collected from medical records):
23. Birth weight
24. Apgar at 1 and 5 mins
25. Admission to neonatal unit
26. Neonatal infection state
27. Signs/symptoms of sepsis
28. Immunological profile at delivery (cord bloods; IgG and IgM)

At 3, 6 and 12 months post-discharge or post-delivery (collected from medical records and case report forms):
29. Breastfeeding rates

Overall trial start date

07/05/2020

Overall trial end date

06/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pregnant women who are admitted to the hospital and have suspected (symptomatic) or confirmed COVID-19 infection and up to 2 weeks post-delivery
2. Age ≥18 years

Note that women admitted for any reason, including non-COVID-19 related reasons such as obstetric reasons, will be included.

Pregnant women may also be identified via the COVIDENCE-UK study (NCT04330599), a national observational cohort study of individuals enrolled from the community that can be potentially diagnosed with COVID-19.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Patients unwilling to give consent
2. Unable to understand sufficient English, and no translator or translation services are available

Recruitment start date

20/05/2020

Recruitment end date

13/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts Health NHS Trust
The Royal London Hospital Whitechapel Rd Whitechapel
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7275/6574
research.governance@qmul.ac.uk

Sponsor type

University/education

Website

http://www.jrmo.org.uk/

Funders

Funder type

Charity

Funder name

February Foundation (UK Charity Reg. 1113064, Funds to pump-prime COVID-19 research)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers will publish the findings of the work in open access academic journals and run open discussion forums to disseminate the work beyond the scientific and clinical community. They will work with key community organisations such as Katie’s Team, East London women’s networks to communicate the findings and plan future work. Additional files are not currently available.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/05/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/05/2020: Trial's existence confirmed by the NIHR.