NCT04679272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

December 20, 2020

Last Update Submit

February 26, 2021

Conditions

Keywords

DMARDsBiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Critical care transfer rate for COVID-19 and death due to COVID-19

    1 day

  • Pulmonary comorbidities, corticosteroids or DMARDs use

    1 day

  • Age

    1 day

  • Number of Participants with co-morbidities

    1 day

  • Type of clinical presentation

    1 day

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Padern Guillaume, physician

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 22, 2020

Study Start

December 1, 2020

Primary Completion

January 30, 2021

Study Completion

February 1, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations