CClinicalTrials.gg
CompletedNCT04500639OTC℞&COVID19Updated Apr 14, 2023

Over-the-counter Medications & COVID-19

An observational study in SARS-CoV-2 Infection and Covid19, sponsored by University of Alberta. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by University of Alberta · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
461
Sex
All
01

Study summary

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.

02

Conditions studied

  • SARS-CoV-2 Infection
  • Covid19

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Keywords

  • Ibuprofen
  • Over-the-counter medications
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 461 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Albertans seeking testing for COVID-19 are eligible for inclusion in the study. Invitation letters will be sent to all individuals with positive test results and a random sample of individuals with negative test results.

Inclusion criteria

  • Residents of the province of Alberta tested for COVID-19 since March 1, 2020

Exclusion criteria

Exclusion Criteria:

  • Individuals who are currently hospitalized, who died, or who do not have contact information in the COVID-19 test record
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
461 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Ibuprofen exposure for symptom management

    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.

    Time frame: Prior to COVID-19 testing

Secondary outcomes

  1. Exposure to other drugs implicated in COVID-19 severity

    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.

    Time frame: Prior to COVID-19 testing

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Study locations

1 site
  • University of Alberta
    Edmonton, Alberta, Canada
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References and documents

Individual participant data

Plan to share: Undecided — A data management plan will be posted on https://portagenetwork.ca/ when it is available.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04500639
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Aug 5, 2020
Start date
Jul 23, 2020
Primary completion
Jan 14, 2022
Completion
May 27, 2022
Last update
Apr 14, 2023

Study contacts

Scot Simpson, PharmD, MSc
principal investigator · Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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