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

• Conditions: Rare Diseases; Autoimmune Diseases; Chronic Inflammatory Rheumatism; SARS-CoV2 Infection
• Interventions: Other: no intervention

• Registration Number: NCT05026892
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Last Update Submitted: 2021-08-27
• Study First Posted: 2021-08-30
• Last Update Posted: 2021-08-30
• Primary Completion: 2021-12
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
moderate to severe	no intervention	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
begining to moderate	no intervention	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

Primary Outcome Measures

Name	Time	Method
risk factors associated with severity	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.

Secondary Outcome Measures

Name	Time	Method
risk factors associated with severe form	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)
risk factors associated with death	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)

Trial Locations

Locations (1)

Bicêtre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France