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NCT05197621 · ClinicalTrials.gov registry record
The Impact of COVID-19 on Maternal and Neonatal Outcomes
A clinical trial of COVID-19 and Pregnancy; Infection, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT05197621: Recruiting study of COVID-19 and Pregnancy; Infection, sponsored by Johns Hopkins University.
NCT05197621 is a study of COVID-19 and Pregnancy; Infection that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 300 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05197621, a study of COVID-19 and Pregnancy; Infection, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL mRNA COVID-19 vaccine (Pfizer or Moderna)
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-04-13 |
| Est. Completion | 2028-05-05 |
What NCT05197621 shows while recruiting
NCT05197621 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which mRNA COVID-19 vaccine (Pfizer or Moderna) is the first listed.
NCT05197621 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05197621 about?
NCT05197621 is a clinical study titled "The Impact of COVID-19 on Maternal and Neonatal Outcomes". 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 ...
What is the current status of trial NCT05197621?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2020-04-13. Estimated completion is 2028-05-05.
What conditions does trial NCT05197621 study?
This clinical trial studies the following conditions: COVID-19, Pregnancy; Infection.
What interventions are being tested in trial NCT05197621?
The interventions under investigation include: mRNA COVID-19 vaccine (Pfizer or Moderna) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05197621?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05197621 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05197621's enrollment target sits among peer trials
300 139th of 298 higher than 157 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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