Over-the-counter Medications & COVID-19

NCT04500639 | Completed

• 1 other identifier: Pro00100243
• Study Type: observational
• Target: 461
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection; Covid19

Keywords

Ibuprofen; Over-the-counter medications

Outcome Measures

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.

  Prior to COVID-19 testing

Secondary Outcomes (1)

• Exposure to other drugs implicated in COVID-19 severity

  Prior to COVID-19 testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Scot Simpson, PharmD, MSc

  Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 5, 2020
• Study Start: July 23, 2020
• Primary Completion: January 14, 2022
• Study Completion: May 27, 2022
• Last Updated: April 14, 2023

Record last verified: 2022-04

Locations

CA (1)