COVID-19NCT04834752
Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19
An observational study of COVID-19, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 400,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
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).
Read the 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.
- Conditions
- COVID-19
- Being tested
- No intervention (Retrospective Cohort Observational)
- Keywords
- COVID-19, Proton pump inhibitor, H2 receptor antagonist
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (Retrospective Cohort Observational)Other
Also called PPI: Rabeprazole, Pantoprazole, Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, H2RA: Famotidine, Cimetidine, Nizatidine, Ranitidine
History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed.
| Study group | Role | What they receive |
|---|---|---|
| Patients tested for COVID-19 | Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR) Receives: Other: No intervention (Retrospective Cohort Observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 60 days
Secondary outcomes (4)
Intensive care unit admission rate
Intensive care unit admission rate of patients who were diagnosed with COVID-19
Measured: 60 days
Mechanical ventilator application rate
Mechanical ventilator application rate of patients who were diagnosed with COVID-19
Measured: 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
Measured: 60 days
Rates of vasopressor and inotrope use
Rates of vasopressor and inotrope use of patients who were diagnosed with COVID-19
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, Soo-Jeong Cho, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834752
- Sponsor's protocol ID
- 2102-004-1192
- Status last verified
- Nov 2024
- First submitted
- 31 Mar 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04834752
- Acronym / sponsor ID
- 2102-004-1192
- Conditions
- COVID-19
- Keywords
- COVID-19, Proton pump inhibitor, H2 receptor antagonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients tested for COVID-19 | – | Other: No intervention (Retrospective Cohort Observational)Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (Retrospective Cohort Observational)Also: PPI: Rabeprazole, Pantoprazole, Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, H2RA: Famotidine, Cimetidine, Nizatidine, RanitidineHistory of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed. | Other | Patients tested for COVID-19 |
Primary outcome
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
Mortality
Time frame: 60 days
Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge)
4 secondary outcomes
Intensive care unit admission rate
Time frame: 60 days
Mechanical ventilator application rate
Time frame: 60 days
Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula)
Time frame: 60 days
Rates of vasopressor and inotrope use
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 test positivity (time frame: Through test completion, an average of 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.