Over-the-counter Medications & COVID-19

Covid19 Clinical Trial

— OTC?&COVID19  

Official title:

Do Common Medications Alter the Course of COVID-19?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500639
• Other study ID #: Pro00100243
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: May 27, 2022

Study information

• Verified date: April 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: May 27, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Prior to COVID-19 testing