Predictive Factors for COVID-19 in Rheumatology

NCT ID: NCT04567576

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-10-31

Brief Summary

We seek to study the behaviour of Coronavirus infection in patients with rheumatological and/or autoimmune comorbidities, understood as a particular pathophysiological universe with its own risks and eventual benefits, until now fully hypothetical to be confirmed by means of real and recent evidence. On March 12, 2020, an initiative called the Global Alliance for COVID-19 in Rheumatology (The COVID-19 Rheumatology Alliance) arises, as a rapid response of international coordination whose ultimate goal is to serve as help or guideline for all those doctors who seek be faced with receiving, evaluating, understanding and caring for a patient with rheumatological and / or autoimmune diseases in relation to the imminent risk of COVID-19.

Detailed Description

Within this context, this study seeks to use the information registered by the Fundación Santa Fe de Bogotá University Hospital as a participating centre. It is intended, under a prospective cohort methodology, to identify, analyze and compare predictive factors of the clinical course of COVID-19 in patients with baseline diagnoses of rheumatological or autoimmune diseases with the intention of establishing well-founded parameters that contribute to the improvement in terms of strategies of prevention, management and prognosis; benefiting both directly treating physicians and patients, as well as indirectly a health system that is predicted to be pushed to the limit as time passes.

Conditions

Rheumatic Diseases; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed

Patients with underlying rheumatological or autoimmune diseases who have a confirmed infection by 2019-nCoV (COVID-19) who at the time of diagnosis (of infection) receive pharmacological treatment with disease modifying antirheumatic drugs (DMARDs).

Disease-modifying antirheumatic drugs (DMARDs)

Intervention Type: DRUG

Within a non-experimental setting, the routine disease-modifying antirheumatic drugs (DMARDs) prescription will be evaluated as the "exposure".

Un-exposed

Patients with underlying rheumatological or autoimmune diseases who have a confirmed 2019-nCoV (COVID-19) infection who at the time of diagnosis (of infection) are not receiving pharmacological treatment with disease-modifying antirheumatic drugs (DMARDs).

No interventions assigned to this group

Interventions

Disease-modifying antirheumatic drugs (DMARDs)

Within a non-experimental setting, the routine disease-modifying antirheumatic drugs (DMARDs) prescription will be evaluated as the "exposure".

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Older than 18 years.
• Have a diagnosis of a rheumatological disease and / or an autoimmune disease by meeting its own and standardized classification criteria.
• Confirmed diagnosis of COVID-19 by RT-PCR test
• Being a patient at the Fundación Santa Fe de Bogotá University Hospital.
• Be enroled in the registry of the Global Alliance for COVID-19 in Rheumatology.

Exclusion Criteria

• Loss of follow-up due to referral to an institution other than the Fundación Santa Fe de Bogotá University Hospital, before documenting the outcome of his clinical picture.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Kevin Maldonado Cañón

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FPColCOVIDReuma2020

Identifier Type: -

Identifier Source: org_study_id