Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— ProCOVRA  

Official title:

Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679272
• Other study ID #: RECHMPL20_0682
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Confirmed COVID-19 diagnosis (positive PCR or serology) in RA patients or healthy controls.

Exclusion criteria:

• Age under 18 years old
• Suspected COVID-19 diagnosis (typical symptoms without a positive PCR or serology)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Covid19
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization rates for COVID-19	Proportion of hospitalized patients in RA group or control group. From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Secondary	Critical care transfer rate for COVID-19 and death due to COVID-19	Proportion of patients transferred in critical care for COVID-19 or deaths due to COVID-19 From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Secondary	Pulmonary comorbidities, corticosteroids or DMARDs use	Type and severity of patients pulmonary comorbidities and treatment by corticosteroids or DMARDs in RA group From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Secondary	Age	Patients demographics From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Secondary	Number of Participants with co-morbidities	Patients comorbidities From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Secondary	Type of clinical presentation	Patients COVID-19 clinical presentation From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Secondary	Type of associated treatments	From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day