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Coronavirus InfectionRISCNCT04383899

Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019

An observational study of Coronavirus Infection, run by University Hospital, Bordeaux.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities. This was attributed to: 1. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronavirus Infection
What is being tested?
Questionnaire
How many people
0 participants
Where
No sites listed yet
Study dates
30 Sep 2020to 30 Nov 2020
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: Patients will be screened at the time of their visit to the participating hospital center; i.e. at the ambulatory screening center adjacent to the hospital not necessarily resulting in patient hospitalization, or directly on admission at the appropriate hospital department (emergencies, intensive care or others).

Who may be able to join

  • All patients tested for COVID-19 in hospital centers participating to the study.
  • No exclusion Criteria.

Who cannot join

None listed.

About this study

Official title: Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019 (COVID-19) Infections: a Case-control Study

It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities.

This was attributed to:

Read more
  1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells,
  2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression,
  3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival.

However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection.

Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms.

Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction.

EMA remains prudent about this assertion

In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations.

It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection.

Read the detailed description

It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities (published in a french journal called "Le Monde" = The world).

This was attributed to:

  1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells.This is based on a single study in streptozotocin-induced diabetic rats where ibuprofen decreases cardiac fibrosis. There seems to be no study in man. (https://www.dw.com/en/coronavirus-confusion-about-safety-of-ibuprofen/a-52824043) These authors noted an increased risk of severe COVID-19 in patients with hypertension or diabetes, and a possible role of Angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) which also upregulate ACE-2, as do also thiazolidinedione antidiabetic drugs. The relevance of this up-regulation seems disputed.
  2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression.
  3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival. A meta-analysis of fever reduction in children found no difference on outcomes between paracetamol and ibuprofen.

However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection.

Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms.

Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction.

EMA remains prudent about this assertion (EMA gives advice on the use of non-steroidal anti-inflammatory drugs for COVID-19, 18 March 2020 EMA/136850/2020).

These findings raise the question of

  1. an indication bias, where more severe cases with more symptoms and higher fever might not respond well to the first line antipyretic paracetamol, so that ibuprofen was then used. (reverse causality) The same has been described with soft-tissue infection
  2. the reality of an increased risk in patients chronically on drugs that upregulate ACEII, such as NSAIDs, antihypertensive drugs and especially ACEI or ARB, or antidiabetic drugs and especially thiazolidinediones.
  3. the impact of concomitant or pre-existing diseases such as diabetes, hypertension or heart failure.

In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations.

It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection, to explore these different questions.

Being tested
Questionnaire
Keywords
NSAID, Ibuprofen, chronic pathology
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    All patients testing positively for COVID-19, with completed questionnaires. As appropriate, the duration of the study will be at least the time to complete the questionnaire for non-hospitalized patients, and for those who are hospitalized, they will be followed until hospital discharge or death to ascertain outcome.

Study groups in NCT04383899
Study groupRoleWhat they receive
Case patientPatients from the cohort with severe coronavirus infection necessitating intensive care (artificial ventilation) with ulterior recovery or fatal outcome.
Receives: Other: Questionnaire
Control patientAll patients from the cohort with non-severe coronavirus infection, who were not admitted to hospital or who were admitted to hospital but without the need for intensive care, and who recovered.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe medications used prior to admission associated with worse infection in COVID-19 patients in France.

    Describe medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions on existing pathology, drugs administrated symptom onset and when, hospitalisation. Each questions have a multiple choice.

    Measured: At inclusion day

  2. Quantify medications used prior to admission associated with worse infection in COVID-19 patients in France.

    Quantify medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions: existing pathology, drugs administrated symptoms onset and when, hospitalisation. Each questions have a multiple choice.

    Measured: At inclusion day

Secondary outcomes (2)
  1. Describe other patient characteristics with worse infection in COVID-19 patients in France.

    Describe patient characteristics thanks to the same questionnaire.

    Measured: At inclusion day

  2. Quantify other patient characteristics with worse infection in COVID-19 patients in France.

    Quantify patient characteristics thanks to the same questionnaire.

    Measured: At inclusion day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start30 Sep 2020 (estimated)
  3. Primary completion31 Oct 2020 (estimated)
  4. Study completion30 Nov 2020 (estimated)

Why it stopped: Ibuprofen is not prescribed during coronavirus pandemic, so the study is stopped

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04383899
Sponsor's protocol ID
CHUBX 2020/13
Acronym
RISC
Status last verified
Feb 2021
First submitted
7 May 2020
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Infection, run by University Hospital, Bordeaux.

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 2 inclusion and 0 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: withdrawn, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Describe medications used prior to admission associated with worse infection in COVID-19 patients in France. (time frame: At inclusion day). The study lists 2 primary outcomes in all. 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 25 Feb 2021.

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