Clinical trial NCT05026892: Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases
Official title: Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
First posted: 2021-08-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: risk factors associated with severity
timeFrame: during covid infection
Secondary outcomes:
measure: risk factors associated with severe form
timeFrame: during covid infection
measure: risk factors associated with severe form
timeFrame: during covid infection
measure: risk factors associated with death
timeFrame: during covid infection
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hospital
Study officials:
References: