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AzTrials

COVID-19NCT04465474

Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

An observational study of COVID-19, run by Chinese University of Hong Kong at 10 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Non Intervention
How many people
3,000 participants
Where
10 sitesin 3 countries
Study dates
1 May 2020to 31 Dec 2024
How long will I take part?
6 Months
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Pregnant women

Who may be able to join

  • Pregnant women who attended for Down syndrome screening (DSS) at 11-13 weeks
  • Had serum sample taken between 1 November 2019 and 1 June 2020 consented for stored serum for future research
  • Intended to deliver at the booking hospital.
  • Objective 2: SARS-CoV-2 and pregnancy loss
  • •Pregnant women presenting with first and second trimester miscarriage in Hong Kong and Spain, as well as those with stillbirth during periods of 6 and 12 months, respectively.
  • Objective 3: Pregnancy course and perinatal outcome
Show all 11Show fewer
  • •Pregnant women affected by COVID-19
  • Objective 4: Vertical transmission
  • •Pregnant women affected by COVID-19
  • Objective 5: Potential mechanisms for vertical transmission
  • •Pregnant women affected by COVID-19

Who cannot join

None listed.

Trial locations and contacts

10 sites in 3 countries.

Liona POON contact

(852) 3505 2582

liona.poon@cuhk.edu.hk

Equal CHEN contact

(852) 3505 1536

equalchen@cuhk.edu.hk

10 sites in 3 countries

Hong Kong8 sites, 8 recruiting

  • Kwong Wah Hospital

    Hong Kong

    Wing Cheong LEUNG, MBBS, MRCOG, FHKAM, FHKCOG, 3517 5053, leungwc@ha.org.hk

    Recruiting

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

    Chung Nin LEE, MBBS, MMedSc, FRCOG, FHKCOG, 2595 6815, lcnz01@ha.org.ha

    Recruiting

  • Princess Margaret Hospital

    Hong Kong

    Tsz-Kin LO, MBBS, MRCOG, FHKCOG, lotk@ha.org.hk

    Recruiting

  • Queen Elizabeth Hospital

    Hong Kong

    Wei Ling Teresa MA, FRCOG, FHKAM, 3506 2246, mawlt@ha.org.hk

    Nga Yui, Florrie YU, MBChB, MRCOG, FHKAM (O&G)

    Recruiting

  • Queen Mary Hospital

    Hong Kong

    Ka Wang CHEUNG, MBBS, MRCOG; FHKCOG; FHKAM, 2255 4267, ckw028a@ha.org.hk

    Recruiting

  • The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong

    Liona Chiu Yee Poon, MBBS, MRCOG, MD, (852) 3505 2582, liona.poon@cuhk.edu.hk

    Equal CHEN, (852) 3505 1536, equalchen@cuhk.edu.hk

    Recruiting

  • Tuen Mun Hospital

    Hong Kong

    Po Lam SO, 2468 5918, soplp@ha.org.hk

    Recruiting

  • United Christian Hospital

    Hong Kong

    Choi Wah KONG, MBChB, MRCOG, FHKAM, FHKCOG, 3949 3444, kcw305@ha.org.hk

    Recruiting

Other trials in Hong Kong

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality

    Huixia YANG, MD, PhD, yanghuixia@bjmu.edu.cn

    Recruiting

Other trials in China

Spain1 site, 1 recruiting

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Madrid

    Maria del Mar GIL, PhD, mariadelmar.gil@ufv.es

    Recruiting

Other trials in Spain

About this study

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.

Read the detailed description

With over 10 million individuals infected worldwide, the coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global public health crisis. It is recognized that pregnant women are at an increased risk of acquiring viral respiratory infection and developing severe pneumonia due to the physiologic changes in their immune and cardiopulmonary systems. Previous studies have attempted to determine maternal and perinatal outcome and potential risk of vertical transmission in pregnant women affected by COVID-19, however, relevant clinical data and biological samples have not been collected in a systematic manner. The research project will engage in collaborative research across obstetricians/maternal-fetal medicine subspecialists, gynecologist, infectious disease specialists, pediatrician, developmental and molecular biologists and bioinformatician between the CUHK, China and Spain. The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.

Results generated will inform obstetrics and gynecology, pediatric and infectious disease scientific communities as well as public health specialists and policy makers regarding: (1) the estimated seroconversion rate in women of childbearing age; these results will help (i) improve the approach to care for pregnancy and childbirth during the COVID-19 outbreak; and (ii) formulate preventive measures to be implemented specifically for pregnant women in reducing risk of infection and associated complications to both the women and their unborn child; (2) the impact of COVID-19 on maternal and perinatal outcomes; data from high-quality research will inform practice during the COVID-19 outbreak, guiding healthcare professionals on how to adjust the management approach to infected pregnant women and the exact risks the infection poses to the babies; (3) the risk of vertical transmission at different stages of pregnancy and its sequelae; findings of this study will guide counselling, decision making and clinical management; (4) the identification of cellular site of viral entry and replication in the maternal-fetal interface that would be instrumental in designing therapeutic measures to cease vertical transmission and developing therapeutic treatments.

Conditions
COVID-19
Being tested
Non Intervention
Keywords
pregnancy, vertical transmission, pregnancy loss, ACE2 TMPRSS2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non InterventionOther

    It's an observational study, no intervention involves.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion during pregnancy - DSS1

    Mother

    Measured: At DSS1 (Around 11-13 weeks gestation)

  2. Seroconversion during pregnancy - At delivery

    Mother

    Measured: At Delivery

  3. Pregnancy loss

    Mother (1st); Mother and abortus/stillborn baby(2nd)

    Measured: At pregnancy loss

  4. Pregnancy course and perinatal outcome

    Mother and Baby

    Measured: From date of recruited until the date of delivery

  5. Vertical transmission

    Mother and Baby

    Measured: At Newborn 0 hours of life, mother immediately after delivery

  6. Vertical transmission

    Mother and Baby

    Measured: At Newborn 7 days of life

  7. Vertical transmission

    Mother and Baby

    Measured: At Newborn 14 days of life

  8. Vertical transmission

    Mother and Baby

    Measured: At Newborn 6 months of life

  9. Vertical transmission

    Mother and Baby

    Measured: At Newborn 18 months of life

  10. Potential mechanisms for vertical transmission 1) placental barrier, 2) immune response and 3) fetal damage of vertical transmission and mechanism in SARS-CoV-2 infection.

    Mother and Baby

    Measured: through study completion, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start1 May 2020
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Other
Time perspective
Other
Enrolment
3,000 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04465474
Sponsor's protocol ID
COVID-MAP
Status last verified
Feb 2024
First submitted
3 Jul 2020
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Chinese University of Hong Kong at 10 sites in 3 countries.

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 11 inclusion and 0 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Hong Kong, China, Spain. 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 Liona POON ((852) 3505 2582, liona.poon@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion during pregnancy - DSS1 (time frame: At DSS1 (Around 11-13 weeks gestation)). The study lists 10 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 NCT04465474.

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 8 Feb 2024.

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Clinical Trial NCT04465474 | AzTrials