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

COVID-19 Clinical Trial

Official 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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04834752
• Other study ID #: 2102-004-1192
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Seoul National University Hospital
• Contact: Bokyung Kim, M.D.
• Phone: +82-2-2072-8112
• Email: lovebkim1119[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality	Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge)	60 days
Secondary	Intensive care unit admission rate	Intensive care unit admission rate of patients who were diagnosed with COVID-19	60 days
Secondary	Mechanical ventilator application rate	Mechanical ventilator application rate of patients who were diagnosed with COVID-19	60 days
Secondary	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
Secondary	Rates of vasopressor and inotrope use	Rates of vasopressor and inotrope use of patients who were diagnosed with COVID-19	60 days