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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05026892

Collaborator

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

1,200

Enrollment

Location

Anticipated Duration (Months)

109.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection Rare Diseases Chronic Inflammatory Rheumatism Autoimmune Diseases	Other: no intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

risk factors associated with severe form [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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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