Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19
Effect of Histamine 2 Receptor Antagonist (H2RA) and Proton Pump Inhibitor (PPI) on the Positivity Rates and Clinical Outcomes of Coronavirus Disease-19 (COVID-19).
1 other identifier
observational
400,000
1 country
1
Brief Summary
This retrospective cohort study aims to evaluate the effect of proton pump inhibitor (PPI) or histamine-2 receptor antagonist (H2RA) on the clinical outcomes and positivity rates of Coronavirus Disease-19 (COVID-19).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 29, 2024
November 1, 2024
8 months
March 31, 2021
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
COVID-19 test positivity
Test positivity rates for COVID-19 nasopharyngeal polymerase chain reaction (PCR): number of participants diagnosed with COVID-19 compared to the number participants who were tested for COVID-19
Through test completion, an average of 1 day
Mortality
Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge)
60 days
Secondary Outcomes (4)
Intensive care unit admission rate
60 days
Mechanical ventilator application rate
60 days
Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula)
60 days
Rates of vasopressor and inotrope use
60 days
Study Arms (1)
Patients tested for COVID-19
Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR)
Interventions
History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed.
Eligibility Criteria
Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs were included. Data were obtained from the Korean national health insurance claims-based database (COVID-19 research dataset). Individuals with a Record of a new prescription of NSAID within 1 month of the test date were excluded because NSAID users for early pneumonia symptoms may initiated for PPIs or H2 blockers.
You may qualify if:
- Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs
You may not qualify if:
- Record of a new prescription of non-steroidal anti-inflammatory drugs (NSAID) within 1 month of the test date
- Patients who died within 48 hours after test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Dong-A ST Co., Ltd.collaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical associate professor
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 8, 2021
Study Start
May 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share