Studying the immune response and long-term morbidity of COVID-19 infection in pregnancy

Plain English summary of protocol

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 November 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 Doris Lanz (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.

Study website

Contact information

Dr Doris Lanz
Public

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

ORCID ID	0000-0001-9879-3069

Dr Stamatina Iliodromiti
Scientific

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

ORCID ID	0000-0001-6453-6654

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Queen Mary University of London
University/education

Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom

Phone	+44 (0)20 7882 7275/6574
Email	research.governance@qmul.ac.uk
Website	http://www.jrmo.org.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

14/11/2022: The following changes were made to the trial record:
1. The overall end date was changed from 06/06/2022 to 11/11/2022.
2. The intention to publish date was changed from 14/05/2022 to 01/08/2023.
3. The plain English summary was updated to reflect these changes.
18/08/2020: Contact details updated.
13/05/2020: Trial's existence confirmed by the NIHR.