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

NCT04383899 | Withdrawn

• 1 other identifier: CHUBX 2020/13
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 1.a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells,
2. 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. 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.

Conditions

Coronavirus Infection

Keywords

NSAID; Ibuprofen; chronic pathology

Outcome Measures

Primary Outcomes (2)

• 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.

  At inclusion day

• 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.

  At inclusion day

Secondary Outcomes (2)

• Describe other patient characteristics with worse infection in COVID-19 patients in France.

  At inclusion day

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

  At inclusion day

Study Arms (2)

Case patient

Patients from the cohort with severe coronavirus infection necessitating intensive care (artificial ventilation) with ulterior recovery or fatal outcome.

Other: Questionnaire

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

Interventions

Questionnaire OTHER

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.

Case patient; Control patient

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

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).

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Bordeaux PharmacoEpi: collaborator

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: September 30, 2020
• Primary Completion: October 31, 2020
• Study Completion: November 30, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share