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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04834752
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Soo-Jeong Cho, 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).

Condition or disease Intervention/treatment
COVID-19 Other: No intervention (Retrospective Cohort Observational)

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.

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Study Type : Observational
Estimated Enrollment : 400000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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).
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients tested for COVID-19
Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR)
Other: No intervention (Retrospective Cohort Observational)
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834752


Contacts
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Contact: Bokyung Kim, M.D. +82-2-2072-8112 lovebkim1119@naver.com
Contact: Soo-Jeong Cho, M.D., Ph.D. 82-10-5297-3398 crystal522@daum.net

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Contact: Bokyung Kim, M.D.    +82-2-2072-8112    lovebkim1119@naver.com   
Sponsors and Collaborators
Seoul National University Hospital
Dong-A ST Co., Ltd.
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Responsible Party: Soo-Jeong Cho, Clinical associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04834752    
Other Study ID Numbers: 2102-004-1192
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Soo-Jeong Cho, Seoul National University Hospital:
COVID-19
Proton pump inhibitor
H2 receptor antagonist
Additional relevant MeSH terms:
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COVID-19
Famotidine
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Esomeprazole
Omeprazole
Rabeprazole
Pantoprazole
Lansoprazole
Dexlansoprazole
Ranitidine
Cimetidine
Nizatidine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents