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NCT Number: NCT04834752

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

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).

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention (Retrospective Cohort Observational)

Other

History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed.

Other names: PPI: Rabeprazole, Pantoprazole, Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, H2RA: Famotidine, Cimetidine, Nizatidine, Ranitidine

Primary outcomes

  1. 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

  2. Mortality

    Time frame: 60 days

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

Secondary outcomes

  1. Intensive care unit admission rate

    Time frame: 60 days

    Intensive care unit admission rate of patients who were diagnosed with COVID-19

  2. Mechanical ventilator application rate

    Time frame: 60 days

    Mechanical ventilator application rate of patients who were diagnosed with COVID-19

  3. 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

  4. Rates of vasopressor and inotrope use

    Time frame: 60 days

    Rates of vasopressor and inotrope use of patients who were diagnosed with COVID-19

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A ST Co., Ltd.

Registry information

Official study title

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).

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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