Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients (ProCOVRA)

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population description: *

• Patients with RA, included in the French RMD Covid-19 cohort, with a confirmed COVID-19 diagnosis (positive PCR or serology).
• Patients included in the Montpellier COVID-19 cohort, without autoimmune disease or inflammatory rheumatism, and with a confirmed COVID-19 diagnosis (positive PCR or serology).

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Age	Patients demographics From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
Number of Participants with co-morbidities	Patients comorbidities From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day
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
Type of associated treatments	From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Padern Guillaume, physician, University Hospitals of Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: DMARDs; Biotherapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; COVID-19; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: RECHMPL20_0682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No