Study identification

PURI

https://redirect.ema.europa.eu/resource/44457

EU PAS number

EUPAS44456

Study ID

44457

Official title and acronym

Impact of the COVID-19 epidemic on people with an inflammatory disease (COVIMID)

DARWIN EU® study

No

Study countries

France

Study description

The proposed study will have an important impact in our knowledge on the impact of such outbreaks in Immune-Mediated Inflammatory Diseases (IMID) patients, namely: - Assessment of the incidence of severe COVID-19 cases in IMID patients, - Comparison of incidence of severe COVID-19 infections in IMID patients compared to the general population, - Comparison of incidence of severe COVID-19 infections in IMID patients treated with targeted Immuno-Modulating Agents (IMA) or conventional synthetic agents compared to the general population, - Assessment of a differential impact between IMA (e.g. IL-6 blockade versus other modes of action) or Anti-Retroviral Therapy (ART) (e.g. daranuvir/atazanavir/bictegravir/lopinavir versus other ARTs) on the incidence of COVID-19 infections, - Identification of the impact of COVID-19 infection of untimely drug tapering and discontinuation in IMID patients, in terms of loss of compliance as well as disease flare or related consequences. The results will fuel relevant information to set up clinical practice guidelines for the management of IMID patients and their treatments in the context of emergent outbreaks, and to enhance communication of risk.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Bruno FAUTREL

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

French Ministry of Health
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable