Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases (CovAID)

August 27, 2021 updated by: Assistance Publique - Hôpitaux de Paris
Factors associated with severe forms of COVID-19 infection in patients with inflammatory rheumatic diseases (IRD) or Autoimmune Diseases (AID) are unknown. This unprecedented situation leads to empirical and potentially erroneous advice and recommendations for care. Identifying factors associated with severity, in the context of this pandemic, which is expected to last many months, and possibly years, is crucial for future patients. The objective of this work is to identify the factors associated with the occurrence of severe forms of COVID-19 infection in patients with IRD or AID, by combining analysis of 2 large databases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94270
        • Bicêtre Hospital
        • Contact:

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 known chronic inflammatory rheumatism, auto-immune or auto-inflammatory diseases (Rheumatoid arthritis, Spondyloarthritis, Psoriatic arthritis Lupus, Sjögren's syndrome, Inflammatory Myositis, Systemic Vasculitis, Sarcoidosis, Scleroderma, PPR/Horton's, other ...) with confirmed SARS-Cov-2 infection (COVID-19) whose data are available in the APHP health data center (EDS) or in the french RMD Covid19 cohort

Description

Inclusion Criteria:

  • Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory diseases (Rheumatoid arthritis, Spondyloarthritis, Psoriatic arthritis Lupus, Sjögren's syndrome, Inflammatory Myositis, Systemic Vasculitis, Sarcoidosis, Scleroderma, PPR/Horton's, other ...)
  • At least 18 years old
  • SARS-Cov-2 infection (COVID-19) by biological data (serological or positive Cov-2 PCR) or CT scan images or clinical observations consistent with covid-19 between January 2020 and September 2020
  • data available in the APHP health data center (EDS) or in the french RMD Covid19 cohort

Exclusion Criteria:

  • patients opposed to the use of their data

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
moderate to severe
patients with known inflammatory rheumatism, auto-immune or auto-inflammatory diseases (as define in the inclusion criteria) with moderate to severe or severe form of covid-19
Other: no intervention
no intervention, only collection of data
begining to moderate
Patients with known inflammatory rheumatism, auto-immune or auto-inflammatory diseases (as define in the inclusion criteria) with begnin to moderate or moderate form of covid-19
Other: no intervention
no intervention, only collection of data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk factors associated with severity
Time Frame: during covid infection
Between begining to moderate and moderate to severe group: Severe form is defined by be defined by hospitalization in intensive care unit and/or death. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed.
during covid infection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk factors associated with severe form
Time Frame: during covid infection
in moderate to severe group: Moderate to severe form is defined by be defined by hospitalization for COVID infection. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed. Pooled analysed and Analyses by IRD/AID subset will be performed, since prognosis might differ in the different diseases : IRD (including rheumatoid arthritis and spondyloarthritis), other AID, and systemic vaculitis)
during covid infection
risk factors associated with severe form
Time Frame: during covid infection
in severe group only: Severe form is defined by be defined by hospitalization in intensive care unit and/or death. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed. Analyses by IRD/AID subset will be performed, since prognosis might differ in the different diseases : IRD (including rheumatoid arthritis and spondyloarthritis), other AID, and systemic vaculitis)
during covid infection
risk factors associated with death
Time Frame: during covid infection
Death during COVID-19 infection. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed. Pooled analysed and Analyses by IRD/AID subset will be performed, since prognosis might differ in the different diseases : IRD (including rheumatoid arthritis and spondyloarthritis), other AID, and systemic vaculitis)
during covid infection

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

FAI²R (Auto-immune and auto-inflammatory rare diseases French network)

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 (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200714

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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