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NCT04912700 · ClinicalTrials.gov registry record

The Impact of Vaccination on Severity of Illness in COVID-19

A clinical trial, sponsored by Corewell Health East.

Completed
Registry status
11,834
Enrollment target

NCT04912700: Completed study, sponsored by Corewell Health East.

NCT04912700 is a clinical trial that has completed, run by Corewell Health East. The registered enrollment target is 11,834 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04912700 has completed, sponsored by Corewell Health East.

COMPLETED
Registry status
11,834 participants
Enrollment target

Study Summary

With the FDA's emergency use authorization declaration in December of 2020, the Pfizer-BioNtech vaccine became the first of several vaccines to kick off the mass vaccination effort across the United States against CoronaVIrus Disease 2019 (COVID-19). Subsequently, Moderna as well as Johnson and Johnson both had vaccines receive emergency use authorization. While the Pfizer and the Moderna vaccines both utilize novel mRNA technology, Johnson and Johnson's vaccine uses a viral vector that has been used previously in both the approved European Ebola vaccine and a trial vaccine for HIV. However, none of these vaccine types have previously been approved in the United States. While preliminary data from safety and efficacy trials have shown positive results, actual-world data on its effectiveness is still lacking. Several small cohort studies and one large trial from Israel are currently the only insights into the actual rates of infection, hospitalization, and severe illness among vaccinated individuals. As COVID-19 variants, with the potential to reduce vaccine efficacy, continue to emerge worldwide, there is a need of more data regarding the real-world effectiveness of our current mass vaccination efforts. Vaccination efforts in the State of Michigan have been ongoing since December 2020. Given that approximately 33.7% of the state's population is either partially or fully vaccinated, it is unclear why the number of cases has risen so dramatically or if immunization efforts can help the situation. Given the current situation in the State of Michigan, this study will evaluate the efficacy of COVID-19 vaccination on rates of hospital visits and severe illness when breakthrough Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) infection occurs in a region with high incidence of variant strain disease.

Primary Outcome

Number of participants with encounters at emergency center (EC) and /or hospitalizations with positive COVID-19 test

Interventions

  • BIOLOGICAL COVID-19 vaccine

Trial Details

FieldValue
Enrollment Target 11,834 participants
Start Date 2021-06-01
Est. Completion 2021-06-07
Corewell Health East

106 total trials

What the finished NCT04912700 record still lists

NCT04912700 is an observational study that tracks outcomes without assigning an intervention. Its 11,834 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which COVID-19 vaccine is the first listed.

NCT04912700 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04912700 about?

NCT04912700 is a clinical study titled "The Impact of Vaccination on Severity of Illness in COVID-19". With the FDA's emergency use authorization declaration in December of 2020, the Pfizer-BioNtech vaccine became the first of several vaccines to kick off the mass vaccination effort across the United States against CoronaVIrus Disease 2019 (COVID-19). Subsequently, Moderna as well as Johnson and John...

What is the current status of trial NCT04912700?

This trial is currently completed. The enrollment target is 11,834 participants. The study started on 2021-06-01. Estimated completion is 2021-06-07.

What interventions are being tested in trial NCT04912700?

The interventions under investigation include: COVID-19 vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT04912700?

This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04912700, the US trial registry maintained by the National Library of Medicine. NCT04912700 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.