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

Completed

• Conditions: COVID-19
• Interventions: Other: No intervention (Retrospective Cohort Observational)

• Registration Number: NCT04834752
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2021-05-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients tested for COVID-19	No intervention (Retrospective Cohort Observational)	Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR)

Primary Outcome Measures

Name	Time	Method
Mortality	60 days	Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge)
COVID-19 test positivity	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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of