The Impact of COVID-19 on Maternal and Neonatal Outcomes (NCT05197621)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Johns Hopkins Hospital — Baltimore, Maryland
Age range: 14 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Johns Hopkins Hospital — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (410) 955-4588
Email: cgolden@jhmi.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in COVID-19
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- COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE) — Bethesda, Maryland
- Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans — Baltimore, Maryland
- Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings — Calgary, Alberta
- A Nasal Treatment for COVID-19 — Indianapolis, Indiana
Explore by condition: All COVID-19 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.