Covid19COVID-PRICENCT04659759
COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes
An observational study of Covid19, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 exposure and COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 30 Aug 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum
Who may be able to join
- Diagnosis of COVID-19 in pregnancy or within 6 months post partum
- Planned delivery at Thomas Jefferson University Hospital
Who cannot join
- Declines routine COVID testing on admission
- In active labor/pain/otherwise unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes
This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.
Read the detailed description
This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine
- Conditions
- Covid19
- Being tested
- COVID-19 exposure, COVID-19 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 exposureOther
COVID-19 exposure during pregnancy
COVID-19 vaccineBiological
Receipt of any COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive | Patients diagnosed with COVID-19 during pregnancy or while breastfeeding Receives: Other: COVID-19 exposure | |
| COVID-19 vaccine | Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding Receives: Biological: COVID-19 vaccine | |
| Controls | Reproductive age women exposed to COVID-19 vaccine | |
| Pregnant Control | Pregnant women who delivered at TJUH, COVID negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal COVID-19 serology (IgG and IgM)
IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19
Measured: 6 weeks post partum
Maternal/neonatal IgG and IgM concordance
IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling
Measured: Delivery
Maternal COVID serology time/profile following vaccination
Baseline, 1m, 3m, 6m post second vaccine dose
Measured: 6 months
Breastmilk Serology
Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women
Measured: 6months
Secondary outcomes (6)
Breastmilk Serology
COVID-19 IgG and IgA in breast milk
Measured: Delivery
Breastmilk Serology
COVID-19 IgG and IgA in breastmilk
Measured: 6 weeks post partum
Cytokine
Compare maternal COVID (+) and COVID (-) cytokine panel
Measured: Delivery
Neonatal cytokine
Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery
Measured: Delivery
COVID disease vs vaccination immune response
Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine
Measured: 6 months
COVID vaccine in pregnant vs nonpregnant
Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start17 Nov 2020
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Nemours
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659759
- Sponsor's protocol ID
- 20F.1043
- Acronym
- COVID-PRICE
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT04659759
- Acronym / sponsor ID
- COVID-PRICE / 20F.1043
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Nemours
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 9 Dec 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.
This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.
Detailed description
This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive | – | Other: COVID-19 exposurePatients diagnosed with COVID-19 during pregnancy or while breastfeeding |
| COVID-19 vaccine | – | Biological: COVID-19 vaccinePatients who receive COVID-19 vaccine during pregnancy or while breastfeeding |
| Controls | – | –Reproductive age women exposed to COVID-19 vaccine |
| Pregnant Control | – | –Pregnant women who delivered at TJUH, COVID negative |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum
Key inclusion criteria (2 listed)
- Diagnosis of COVID-19 in pregnancy or within 6 months post partum
- Planned delivery at Thomas Jefferson University Hospital
Key exclusion criteria (2 listed)
- Declines routine COVID testing on admission
- In active labor/pain/otherwise unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 exposureCOVID-19 exposure during pregnancy | Other | COVID-19 Positive |
| COVID-19 vaccineReceipt of any COVID-19 vaccine | Biological | COVID-19 vaccine |
Primary outcome
Maternal COVID-19 serology (IgG and IgM)
Time frame: 6 weeks post partum
IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19
Maternal/neonatal IgG and IgM concordance
Time frame: Delivery
IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling
Maternal COVID serology time/profile following vaccination
Time frame: 6 months
Baseline, 1m, 3m, 6m post second vaccine dose
Breastmilk Serology
Time frame: 6months
Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women
6 secondary outcomes
Breastmilk Serology
Time frame: Delivery
Breastmilk Serology
Time frame: 6 weeks post partum
Cytokine
Time frame: Delivery
Neonatal cytokine
Time frame: Delivery
COVID disease vs vaccination immune response
Time frame: 6 months
COVID vaccine in pregnant vs nonpregnant
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Thomas Jefferson University at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal COVID-19 serology (IgG and IgM) (time frame: 6 weeks post partum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.