<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500639</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100243</org_study_id>
    <nct_id>NCT04500639</nct_id>
  </id_info>
  <brief_title>Over-the-counter Medications &amp; COVID-19</brief_title>
  <acronym>OTC℞&amp;COVID19</acronym>
  <official_title>Do Common Medications Alter the Course of COVID-19?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ibuprofen is one of several common medications implicated in coronavirus disease 2019&#xD;
      (COVID-19) severity. On March 11, the Lancet Respiratory Medicine published a letter stating&#xD;
      ibuprofen can increase angiotensin-converting enzyme 2 (ACE2) expression. On March 14, the&#xD;
      French Minister of Health tweeted that ibuprofen should be avoided because it will aggravate&#xD;
      COVID-19. This concern was echoed by scientists and senior doctors in the British Medical&#xD;
      Journal news on March 17. In response, the World Health Organization (WHO) issued a&#xD;
      recommendation on March 18 to avoid ibuprofen in people with symptoms of COVID-19. However,&#xD;
      the WHO reversed this recommendation the next day because of insufficient evidence. Health&#xD;
      Canada issued a safety alert on March 20 stating there was no evidence that ibuprofen worsens&#xD;
      COVID-19 symptoms. There is some evidence suggesting NSAID use (primarily ibuprofen) can&#xD;
      increase severity of community acquired bacterial pneumonia in hospitalized children and&#xD;
      adults. However, we do not know if ibuprofen use alters the course of COVID-19.&#xD;
&#xD;
      Ibuprofen is an effective analgesic and antipyretic medication. People often use&#xD;
      over-the-counter cough and cold products containing ibuprofen to manage symptoms of a&#xD;
      respiratory tract infection before they seek medical attention. Therefore, exposure to&#xD;
      ibuprofen is highly probable in people with COVID-19 symptoms. Patients, clinicians, and&#xD;
      policy makers need to know if ibuprofen is safe to use in management of COVID-19 symptoms.&#xD;
&#xD;
      This case-control study will explore the association between common medications and COVID-19&#xD;
      severity in a cohort of people tested for SARS-CoV-2 infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">May 27, 2022</completion_date>
  <primary_completion_date type="Actual">January 14, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ibuprofen exposure for symptom management</measure>
    <time_frame>Prior to COVID-19 testing</time_frame>
    <description>Ibuprofen use will be determined from responses to a survey question asking what over-the-counter medications were used to help manage symptoms before testing for COVID-19. Response options include all brand name analgesic and cough and cold products available in Canada, as well as options to list generic brand products containing ibuprofen or acetaminophen.&#xD;
If a participant indicates they used both acetaminophen and ibuprofen to manage symptoms, an additional question will ask for the sequence that these analgesics were started. Responses to this question will help us determine if ibuprofen was added for better symptom relief, presumably because symptoms were severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exposure to other drugs implicated in COVID-19 severity</measure>
    <time_frame>Prior to COVID-19 testing</time_frame>
    <description>Exposure to angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), and pioglitazone will be identified using additional questions in the survey and verified with prescription drug records in the administrative health databases.</description>
  </secondary_outcome>
  <enrollment type="Actual">461</enrollment>
  <condition>SARS-CoV-2 Infection</condition>
  <condition>Covid19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Albertans seeking testing for COVID-19 are eligible for inclusion in the study. Invitation&#xD;
        letters will be sent to all individuals with positive test results and a random sample of&#xD;
        individuals with negative test results.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents of the province of Alberta tested for COVID-19 since March 1, 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are currently hospitalized, who died, or who do not have contact&#xD;
             information in the COVID-19 test record&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scot Simpson, PharmD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ibuprofen</keyword>
  <keyword>Over-the-counter medications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>A data management plan will be posted on https://portagenetwork.ca/ when it is available.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500639
org study id: Pro00100243
nct id: NCT04500639
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Ibuprofen is one of several common medications implicated in coronavirus disease 2019
      (COVID-19) severity. On March 11, the Lancet Respiratory Medicine published a letter stating
      ibuprofen can increase angiotensin-converting enzyme 2 (ACE2) expression. On March 14, the
      French Minister of Health tweeted that ibuprofen should be avoided because it will aggravate
      COVID-19. This concern was echoed by scientists and senior doctors in the British Medical
      Journal news on March 17. In response, the World Health Organization (WHO) issued a
      recommendation on March 18 to avoid ibuprofen in people with symptoms of COVID-19. However,
      the WHO reversed this recommendation the next day because of insufficient evidence. Health
      Canada issued a safety alert on March 20 stating there was no evidence that ibuprofen worsens
      COVID-19 symptoms. There is some evidence suggesting NSAID use (primarily ibuprofen) can
      increase severity of community acquired bacterial pneumonia in hospitalized children and
      adults. However, we do not know if ibuprofen use alters the course of COVID-19.

      Ibuprofen is an effective analgesic and antipyretic medication. People often use
      over-the-counter cough and cold products containing ibuprofen to manage symptoms of a
      respiratory tract infection before they seek medical attention. Therefore, exposure to
      ibuprofen is highly probable in people with COVID-19 symptoms. Patients, clinicians, and
      policy makers need to know if ibuprofen is safe to use in management of COVID-19 symptoms.

      This case-control study will explore the association between common medications and COVID-19
      severity in a cohort of people tested for SARS-CoV-2 infection.
observational model: Case-Control
time perspective: Prospective
measure: Ibuprofen exposure for symptom management
time frame: Prior to COVID-19 testing
description: Ibuprofen use will be determined from responses to a survey question asking what over-the-counter medications were used to help manage symptoms before testing for COVID-19. Response options include all brand name analgesic and cough and cold products available in Canada, as well as options to list generic brand products containing ibuprofen or acetaminophen.
If a participant indicates they used both acetaminophen and ibuprofen to manage symptoms, an additional question will ask for the sequence that these analgesics were started. Responses to this question will help us determine if ibuprofen was added for better symptom relief, presumably because symptoms were severe.
measure: Exposure to other drugs implicated in COVID-19 severity
time frame: Prior to COVID-19 testing
description: Exposure to angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), and pioglitazone will be identified using additional questions in the survey and verified with prescription drug records in the administrative health databases.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Scot Simpson, PharmD, MSc
role: Principal Investigator
affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: A data management plan will be posted on https://portagenetwork.ca/ when it is available.