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

NCT05026892 | Unknown

• 1 other identifier: APHP200714
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV2 Infection; Rare Diseases; Chronic Inflammatory Rheumatism; Autoimmune Diseases

Keywords

SARS-CoV2 Infection; Rare Diseases; Chronic Inflammatory Rheumatism; Autoimmune Diseases; auto-inflammatory diseases

Outcome Measures

Primary Outcomes (1)

• risk factors associated with severity

  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 Outcomes (3)

• risk factors associated with severe form

  during covid infection

• risk factors associated with severe form

  during covid infection

• risk factors associated with death

  during covid infection

Study Arms (2)

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

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

Interventions

no intervention OTHER

no intervention, only collection of data

begining to moderate; moderate to severe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• patients opposed to the use of their data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• FAI²R (Auto-immune and auto-inflammatory rare diseases French network): collaborator

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

COVID-19; Rare Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Central Study Contacts

Raphaele SEROR, Pr

CONTACT

01 45 21 37 59; raphaele.seror@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: August 30, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

FR (1)