Predictive Factors for COVID-19 in Rheumatology

• Conditions: Rheumatic Diseases; Covid19
• Interventions: Drug: Disease-modifying antirheumatic drugs (DMARDs)

• Registration Number: NCT04567576
• Lead Sponsor: Fundación Santa Fe de Bogota

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-28
• Last Update Posted: 2020-09-28
• Study Start: 2020-10
• Primary Completion: 2021-05
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	Disease-modifying antirheumatic drugs (DMARDs)	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).

Primary Outcome Measures

Name	Time	Method
Clinical behavior of the disease // COVID-19	1-12 weeks	It will be considered as 1. Severe, if it meets at least one of the following characteristics (based on what is registered in the main center's database): * If you were hospitalized: What was the highest level of care you required during the illness? →; o Required invasive mechanical ventilation or extracorporeal membrane oxygenation; * If the symptoms did not resolve and the patient was hospitalized: What is the highest level of care that has been required in the course of the present illness so far? o Required mechanical ventilation or extracorporeal membrane oxygenation
Mortality	1-12 weeks	It will be considered as 1. Yes, if it meets at least one of the following characteristics (based on what is registered in the main center's database): • Has the patient died?; o Yes, he passed away