Clinical trial NCT04500639: Over-the-counter Medications & COVID-19
Official title: Do Common Medications Alter the Course of COVID-19?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Covid19
Keywords: Ibuprofen
Over-the-counter medications
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 461
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Ibuprofen exposure for symptom management
timeFrame: Prior to COVID-19 testing
Secondary outcomes:
measure: Exposure to other drugs implicated in COVID-19 severity
timeFrame: Prior to COVID-19 testing
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta
name: Scot Simpson, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References: