Condition category
Infections and Infestations
Date applied
29/04/2020
Date assigned
30/04/2020
Last edited
30/04/2020
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.
There is a need to rapidly collect and pool data on pregnant women affected by suspected or confirmed COVID-19 to inform treatment and preventative strategies in this and future outbreaks. The aim of this study is to create a global registry gathering data on the effect of SARS-CoV-2 infection in pregnancy from healthcare systems around the world. The researchers are endorsed by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and the International Federation of Gynecology and Obstetrics (FIGO) who will support the study through their members and networks.

Who can participate?
Women aged 18-50 who are pregnant and their babies, with suspected or confirmed COVID-19

What does the study involve?
Data will be collected between January 2020 and March 2021 focusing on miscarriage, fetal growth restriction and stillbirth, pre-term delivery and potential transmission to the baby. The study will also collect data on ultrasound diagnosis and neonatal care not included in other more general studies. Data entry can be performed by any healthcare professional in maternity services. The researchers will engage with obstetricians (Attendings/Consultants and those in training) and midwives to ensure data collection is as wide and full as possible. Investigators can register their interest to add data to the registry through the web page (https://pan-covid.org). Once registered they will be asked to provide confirmation of their local approval, which will allow data entry.

What are the possible benefits and risks of participating?
There are no direct benefits or risks of participation, the data gathered will be used to inform treatment and prevention of COVID-19.

Where is the study run from?
Imperial College Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
January 2020 to September 2021

Who is funding the study?
UK Research and Innovation

Who is the main contact?
Dr Edward Mullins
edward.mullins@imperial.ac.uk

Trial website

https://pan-covid.org

Contact information

Type

Public

Primary contact

Dr Edward Mullins

ORCID ID

http://orcid.org/0000-0003-1886-6358

Contact details

Principal Investigator
Queen Charlotte's & Chelsea Hospital
Du Cane Road
London
London
W12 0HS
United Kingdom
+44 (0)20 3313 1111
edward.mullins@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

20QC5917, IRAS 282655

Study information

Scientific title

Pregnancy and Neonatal Outcomes in COVID-19: a global registry of women with suspected COVID-19 or confirmed SARS-CoV-2 infection in pregnancy and their neonates; understanding natural history to guide treatment and prevention

Acronym

PAN-COVID

Study hypothesis

To understand the natural history of COVID-19 in pregnancy, in order to guide treatment and prevention during the outbreak.

Ethics approval

Approved 09/04/2020, North West - Haydock Research Ethics Committee (3rd Floor - Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048387 or +44 (0)2071048165; haydock.rec@hra.nhs.uk), ref: 20/NW/0212

Study design

Observational pregnancy register

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

https://pan-covid.org/Information-for-Participants.php

Condition

COVID-19 (SARS-CoV-2 infection) in pregnancy and neonates

Intervention

The study will form a global disease registry linked with other national data sources for women with suspected COVID-19 or confirmed SARS-CoV-2 in pregnancy and their neonates. Investigators can register their interest to add data to the registry through the web page (https://pan-covid.org). Once registered they will be asked to provide confirmation of their local approval, which will allow data entry. Data will be collected from 01/01/2020 to 31/03/2021 on miscarriage, pre-term delivery, fetal growth restriction and neonatal outcomes, to assess the effect of a SARS-CoV-2 infection.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Confirmed SARS-CoV-2 infection in women in pregnancy or their neonates, measured using routine clinical data from 01/01/2020 to 31/03/2021
2. Suspected SARS-CoV-2 (defined as woman self-isolating for suspected COVID-19 with symptoms, symptoms will be recorded) measured using routine clinical data from 01/01/2020 to 31/03/2021

Secondary outcome measures

1. Incidence of miscarriage measured using routine clinical data from 01/01/2020 to 31/3/2021
2. Incidence of fetal growth restriction and stillbirth measured using routine clinical data from 01/01/2020 to 31/3/2021
3. Incidence of preterm birth measured using routine clinical data from 01/01/2020 to 31/3/2021
4. Incidence of vertical transmission to the neonate measured using routine clinical data from 01/01/2020 to 31/3/2021
5. Co-morbidities measured using routine clinical data from 01/01/2020 to 31/3/2021
6. Medical history measured using routine clinical data from 01/01/2020 to 31/3/2021
7. Details of the delivery of baby/babies measured using routine clinical data from 01/01/2020 to 31/3/2021

Overall trial start date

01/01/2020

Overall trial end date

30/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women aged 18-50 who are pregnant and their babies
2. Suspected COVID-19 or confirmed SARs-CoV-2 infection
3. Delivery or pregnancy loss between January 2020 and March 2021

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Approx. 1000

Participant exclusion criteria

Individuals who do not meet the inclusion criteria

Recruitment start date

01/01/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Czech Republic, Ecuador, Egypt, Estonia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Portugal, Qatar, Romania, Russian Federation, South Africa, Spain, Thailand, Tunisia, Uganda, United Arab Emirates, United Kingdom, United States of America

Trial participating centre

Imperial College Healthcare NHS Trust
Du Cane Road
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

South Kensington
London
SW7 2BU
United Kingdom
+44 (0)20 7589 5111
y.borisova@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research organisation

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The weekly reports of case data will be made available on the study website. In addition, results will be submitted to scientific journals, available as open-access, in Autumn 2021.

IPD sharing statement
CTR, Cardiff University is responsible for building, maintaining, cleaning and analysing the database. All enquiries should be directed to the PI, Edward Mullins (Edward.mullins@imperial.ac.uk) or Julia Townson (townson@cardiff.ac.uk). The data will be available upon request and an agreed/signed data-sharing agreement. De-identified participant data will be made available to the scientific community with as few restrictions as feasible, whilst retaining exclusive use until the publication of major outputs. Cardiff University holds data for 15 years.

Intention to publish date

31/10/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/04/2020: Trial's existence confirmed by the NIHR.