SARS-CoV-2 InfectionOTC℞&COVID19NCT04500639
Over-the-counter Medications & COVID-19
An observational study of SARS-CoV-2 Infection and Covid19, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2 Infection, Covid19
- How many people
- 461 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2020to 27 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Residents of the province of Alberta tested for COVID-19 since March 1, 2020
Who cannot join
- Individuals who are currently hospitalized, who died, or who do not have contact information in the COVID-19 test record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Common Medications Alter the Course of COVID-19?
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
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Prior to COVID-19 testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start23 Jul 2020
- Primary completion14 Jan 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scot Simpson, PharmD, MSc, Principal investigator, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500639
- Sponsor's protocol ID
- Pro00100243
- Acronym
- OTC℞&COVID19
- Status last verified
- Apr 2022
- First submitted
- 4 Aug 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A data management plan will be posted on https://portagenetwork.ca/ when it is available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Common Medications Alter the Course of COVID-19?
- ClinicalTrials.gov ID
- NCT04500639
- Acronym / sponsor ID
- OTC℞&COVID19 / Pro00100243
- Conditions
- SARS-CoV-2 Infection, Covid19
- Keywords
- Ibuprofen, Over-the-counter medications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Residents of the province of Alberta tested for COVID-19 since March 1, 2020
Key exclusion criteria (1 listed)
- Individuals who are currently hospitalized, who died, or who do not have contact information in the COVID-19 test record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ibuprofen exposure for symptom management
Time frame: Prior to COVID-19 testing
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.
1 secondary outcome
Exposure to other drugs implicated in COVID-19 severity
Time frame: Prior to COVID-19 testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Undecided. A data management plan will be posted on https://portagenetwork.ca/ when it is available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scot Simpson, PharmD, MSc principal investigator
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and Covid19, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ibuprofen exposure for symptom management (time frame: Prior to COVID-19 testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.