Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19

Overview

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).

Full Title of Study: “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).”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • Other: No intervention (Retrospective Cohort Observational)
    • History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed.

Arms, Groups and Cohorts

  • Patients tested for COVID-19
    • Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR)

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Mortality
    • Time Frame: 60 days
    • Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge)

Secondary Measures

  • Intensive care unit admission rate
    • Time Frame: 60 days
    • Intensive care unit admission rate of patients who were diagnosed with COVID-19
  • Mechanical ventilator application rate
    • Time Frame: 60 days
    • Mechanical ventilator application rate of patients who were diagnosed with COVID-19
  • Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula)
    • Time Frame: 60 days
    • Oxygen apply (Nasal prong, Facial Mask, High flow nasal cannula) rates of patients who were diagnosed with COVID-19
  • Rates of vasopressor and inotrope use
    • Time Frame: 60 days
    • Rates of vasopressor and inotrope use of patients who were diagnosed with COVID-19

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Dong-A ST Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soo-Jeong Cho, Clinical associate professor – Seoul National University Hospital
  • Overall Contact(s)
    • Bokyung Kim, M.D., +82-2-2072-8112, lovebkim1119@naver.com

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