Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants (CORhum)

February 7, 2022 updated by: University Hospital, Lille
A retrospective monocentric study with large active files of patients monitored for rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in conventional units and/or in intensive care and/or deceased). The results will be compared with those of the general population based on the epidemiological data of Covid-19.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

539

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Lille University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic inflammatory rheumatic diseases who are immunosuppressed: rheumatoid arthritis/spondylarthritis [individualized psoriatic spondyloarthritis and rheumatism]/systemic lupus erythematosus

Description

Inclusion Criteria:

  • Patients with rheumatoid arthritis on conventional synthetic DMARD (csDMARDs) +/- biological DMARD (bDMARDs) or targeted synthetic DMARD (tsDMARDs) +/- corticosteroid therapy meeting ACR/EULAR 2010 classification criteria
  • Patients with spondylarthritison biological DMARD or targeted synthetic DMARD +/- conventional synthetic DMARD +/- non-steroidal anti-inflammatory drugs meeting ASAS classification criteria
  • Patients with systemic lupus erythematosus on hydroxychloroquine +/- conventional synthetic DMARD +/- corticosteroid therapy +/- biological DMARD meeting ACR/EULAR 2019 classification criteria

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient with chronic inflammatory rheumatism
Other: questionnaire assesment
15-minute face-to-face questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analysis of Covid-19-related morbidity and mortality in patients with IRC under IS.
Time Frame: At 6 months
the number of patients with severe Covid-19 who were admitted to a conventional unit and/or an ICU and/or deceased, during the Covid-19 epidemic wave (from March to August 2020) among patients with IRC under IS. The diagnosis of Covid-19 is either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology. The results will be compared with those of the general population based on Covid-19 epidemiological data.
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the frequency of Covid-19 in patients with IRC under IS.
Time Frame: At 6 months
Diagnosis of Covid-19 either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology.
At 6 months
To compare the morbidity and mortality of patients with IRC under IS during the Covid-19 epidemic wave (March to August 2020) with the six months prior to this wave (September 2019 to February 2020).
Time Frame: At 6 months
The number of patients admitted to conventional unit and/or ICU and/or deceased among patients with IRC under IS between the Covid-19 epidemic wave (March to August 2020) and the six-month period preceding it (September to February 2020).
At 6 months
Patients' conduct in relation to their treatment during the epidemic wave (maintenance, modification or discontinuation) and the impact on their disease (loss of remission, flare, corticosteroids requirement and need for switch of DMARD therapy)
Time Frame: At 6 months
The number of patients who maintained, modified, or discontinued their treatment. Treatment modification will be assessed by the number of weeks of treatment not taken, the number of injections not given, the number of delayed or missed infusions. Among those who have modified or stopped their treatment, the impact on their diseases will be evaluated by the loss of remission, the patient's opinion on the notion of relapse, the increase or initiation of corticosteroid therapy and the substantive change in treatment.
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_49
  • 2020-A01650-39 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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