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Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019 (RISC)

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ClinicalTrials.gov Identifier: NCT04383899
Recruitment Status : Withdrawn (Ibuprofen is not prescribed during coronavirus pandemic, so the study is stopped)
First Posted : May 12, 2020
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
Bordeaux PharmacoEpi
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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. 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.


Condition or disease Intervention/treatment
Coronavirus Infection Other: Questionnaire

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019 (COVID-19) Infections: a Case-control Study
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Group/Cohort Intervention/treatment
Case patient
Patients from the cohort with severe coronavirus infection necessitating intensive care (artificial ventilation) with ulterior recovery or fatal outcome.
Other: Questionnaire
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.

Control patient
All 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.
Other: Questionnaire
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.




Primary Outcome Measures :
  1. Describe medications used prior to admission associated with worse infection in COVID-19 patients in France. [ Time Frame: At inclusion day ]
    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.

  2. Quantify medications used prior to admission associated with worse infection in COVID-19 patients in France. [ Time Frame: At inclusion day ]
    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.


Secondary Outcome Measures :
  1. Describe other patient characteristics with worse infection in COVID-19 patients in France. [ Time Frame: At inclusion day ]
    Describe patient characteristics thanks to the same questionnaire.

  2. Quantify other patient characteristics with worse infection in COVID-19 patients in France. [ Time Frame: At inclusion day ]
    Quantify patient characteristics thanks to the same questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

- All patients tested for COVID-19 in hospital centers participating to the study.

No exclusion Criteria.

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04383899    
Other Study ID Numbers: CHUBX 2020/13
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
NSAID
Ibuprofen
chronic pathology
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases