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

Autoimmune Diseases Clinical Trial

— CovAID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05026892
• Other study ID #: APHP200714
• Status: Not yet recruiting
• Start date: August 2021
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Raphaele SEROR, Pr
• Phone: 01 45 21 37 59
• Email: raphaele.seror[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Inflammatory Rheumatism
• Collagen Diseases
• Communicable Diseases
• Infection
• Rare Diseases
• Rheumatic Diseases
• Rheumatic Fever
• SARS-CoV2 Infection

Intervention

Other:
• no intervention
no intervention, only collection of data

Locations

Country	Name	City	State
France	Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	FAI²R (Auto-immune and auto-inflammatory rare diseases French network)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	risk factors associated with severe form	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
Secondary	risk factors associated with severe form	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
Secondary	risk factors associated with death	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