Predictive Factors for COVID-19 in Rheumatology

Covid19 Clinical Trial

Official title:

Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04567576
• Other study ID #: FPColCOVIDReuma2020
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2020
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 31, 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Covid19
• Rheumatic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical behavior of the disease // COVID-19	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	1-12 weeks
Primary	Mortality	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	1-12 weeks