Status:
COMPLETED
COVID-19 Breakthrough Infection in Fully Vaccinated People and in People Who Received a Booster Dose
Lead Sponsor:
Methodist Health System
Conditions:
COVID-19 Pneumonia
COVID-19
Eligibility:
All Genders
18-100 years
Brief Summary
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 Decem...
Detailed Description
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 Decem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 17 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05392075
Start Date
March 15 2023
End Date
August 17 2023
Last Update
October 19 2023
Active Locations (1)
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1
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203