NCT04834752

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

March 31, 2021

Last Update Submit

November 26, 2024

Conditions

Keywords

COVID-19Proton pump inhibitorH2 receptor antagonist

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Intensive care unit admission rate

    60 days

  • Mechanical ventilator application rate

    60 days

  • Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula)

    60 days

  • Rates of vasopressor and inotrope use

    60 days

Study Arms (1)

Patients tested for COVID-19

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

Other: No intervention (Retrospective Cohort Observational)

Interventions

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

Also known as: PPI: Rabeprazole, Pantoprazole, Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, H2RA: Famotidine, Cimetidine, Nizatidine, Ranitidine
Patients tested for COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs were included. Data were obtained from the Korean national health insurance claims-based database (COVID-19 research dataset). Individuals with a Record of a new prescription of NSAID within 1 month of the test date were excluded because NSAID users for early pneumonia symptoms may initiated for PPIs or H2 blockers.

You may qualify if:

  • Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

PantoprazoleOmeprazoleEsomeprazoleLansoprazoleDexlansoprazoleCimetidineNizatidineRanitidine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGuanidinesAmidinesImidazolesAzolesThiazolesFurans

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 8, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations