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Clinical Trials/NCT04834752
NCT04834752
Completed
Not Applicable

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).

Seoul National University Hospital1 site in 1 country400,000 target enrollmentMay 1, 2021
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Seoul National University Hospital
Enrollment
400000
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
last year

Overview

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).

Detailed Description

Previous researches on the association between the use of PPI and H2RA and the treatment and prevention of COVID-19 have reported inconsistent findings. This study aimed to evaluate the effect of H2 receptor antagonists and proton pump inhibitors on the clinical outcomes and positivity rates of COVID-19 using the Korean National Health Insurance (NHI) data. This is a retrospective cohort study using the NHI COVID-19 dataset, which includes health insurance data of individuals who underwent COVID-19 PCR test in South Korea. This study aims to evaluate the effect of the use of PPI and H2RA on the positivity rates and clinical outcomes of COVID-19.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
December 31, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Soo-Jeong Cho

Clinical associate professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Mortality

Time Frame: 60 days

Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge)

COVID-19 test positivity

Time Frame: Through test completion, an average of 1 day

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

Secondary Outcomes

  • Rates of vasopressor and inotrope use(60 days)
  • Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula)(60 days)
  • Intensive care unit admission rate(60 days)
  • Mechanical ventilator application rate(60 days)

Study Sites (1)

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