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COVID-19 Breakthrough Infection in Fully Vaccinated People and in People Who Received a Booster Dose

NCT05392075

CompletedN/A

Sponsor: Methodist Health System

Conditions: COVID-19 Pneumonia, COVID-19

Interventions: Pfizer COVID-19 mRNA vaccine, Moderna COVID-19 mRNA vaccine

Countries: United States

A novel coronavirus, SARS-CoV-2 (formerly known as the 2019 novel coronavirus \[2019-nCoV\]) was identified as the agent that caused an outbreak of pneumonia (termed COVID-19) in Wuhan, China in December 2019. The virus quickly spread to other countries and on March 11, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. By March 2021, many nations and organizations embarked on finding a cure or vaccine for this devastating viral infection. The Pfizer COVID-19 mRNA vaccine was the first to obtain emergency use authorization (EUA) from the Food \& Drug Administration (FDA) on December 11, 2020, followed by the Moderna COVID-19 mRNA vaccine on December 18, 2020, and the Janssen COVID-19 viral vector vaccine on February 27, 2021. The mRNA vaccines and the viral vector vaccine are designed based on the spike protein of SARS-COV-2. These vaccines had been administered to millions of Americans prior to July 2021.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Be male or female, ≥18 years of age
* Be willing and able to provide informed consent if needed; in cases where an abbreviated telephone informed consent needs to be obtained, the patient must understand and speak English.
* Has received at least two doses of an mRNA vaccine or one dose of the Janssen COVID-19 vaccine
* Had a positive COVID-19 antigen or PCR test at least 14 days after the last COVID-19 vaccine.
* Patients who had a diagnosis of COVID-19 at a Methodist Facility within the last 30 days preceding their admission must have the result in their electronic medical record.

Exclusion Criteria:

* Does not satisfy all of the inclusion criteria.
* The patient had a COVID-19 infection diagnosed at a non-Methodist facility within the last 30 days.

Locations (1)

Dallas, Texas, United States