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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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COVID-19

Intervention / Treatment
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* Other: No intervention (Retrospective Cohort Observational)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients tested for COVID-19<br>Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR) | Other: No intervention (Retrospective Cohort Observational)<br>* History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed.<br>* Other names: H2RA: Famotidine, Cimetidine, Nizatidine, Ranitidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Proton pump inhibitor, H2 receptor antagonist