An observational study in COVID-19 and Pregnancy; Infection, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to female participants aged 14 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Johns Hopkins University · Observational
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Among 19 studies in COVID-19 by Johns Hopkins University — 2 open to participants now, 2 under way, none of them phase 3. COVID-19 · Johns Hopkins University.
Among the 19 studies in COVID-19 by Johns Hopkins University, this one is one of 12 that started in 2020, is one of 6 observational ones, and was the 15th registered.
7,993 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →2 of the 19 studies in COVID-19 by Johns Hopkins University are open now, in 1 country. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.
This study: 14 Years to 55 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 1
First in 2020; this study’s year is marked. 12 started in 2020.
This study's planned enrollment of 300 is above the median of 268 across 3,209 observational studies indexed under COVID-19.
Median enrollment 35 across the 13 interventional studies, 32 across the 6 observational. Of the 15 that completed or were terminated, 6 (40%) have results posted.
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Johns Hopkins University is the lead sponsor of 1,816 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
2 of the studies in COVID-19 by Johns Hopkins University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06128928Johns Hopkins UniversityConnecting Friends and Health Workers to Boost COVID-19 Vaccination in Latino Communities | 2026-12-31 |
| NCT05197621Johns Hopkins UniversityThe Impact of COVID-19 on Maternal and Neonatal Outcomes | 2027-05-05 |
Add all 2 to your calendar (.ics) → With an account.
Among the 19 studies in COVID-19 by Johns Hopkins University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection.
The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.
All pregnant women, aged 14-55, receiving prenatal care from Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and/or a third dose booster during their pregnancy, or, patients who have had a positive COVID-19 test during their pregnancy or at the time of admission to Labor \& Delivery.
Inclusion Criteria for Vaccine Arm:
Exclusion Criteria:
Inclusion Criteria for Sample Collection Arm:
Exclusion Criteria:
Pregnant women who are planning to receive an mRNA COVID vaccine (Pfizer of Moderna), and/or a third booster vaccine, who consent to maternal blood collection before receipt of the vaccine and at 6 time points after receiving the vaccine and/or booster.
Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)
Pregnant patients who have tested positive for COVID during their pregnancy or have a positive COVID test at the time of admission to Labor \& Delivery, who consent to collection of maternal blood, cord blood, placenta, and breast milk samples, as well as neonatal blood and stool samples. Patients testing negative for COVID at the time of admission to Labor \& Delivery can be enrolled in the study as controls.
mRNA vaccine received at any time during pregnancy course
Also known as: Pfizer or Moderna COVID-19 vaccine
Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
Evaluation of biospecimens (maternal \& neonatal blood, cord blood, placenta samples, neonatal stool samples \& breast milk) collected from recently delivered pregnant women and neonates for biomarkers of placental inflammation and early onset neonatal sepsis.
Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection
To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
Investigation of antibody responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations).
Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection
To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
Identification of T cell responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations).
Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection
To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people
Determination of SARS-CoV-2 vaccine efficacy and characterization of breakthrough infections with SARS-CoV-2 variants that evaded vaccine induced immunity.
Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2020 (actual). Primary completion is estimated for May 2027, 84 months after the start.
Of 1,641 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 84 months is above that.
Counting every sponsor, half of 1,775 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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