Predictive Factors for COVID-19 in Rheumatology

NCT04567576 | Unknown DMC

• 1 other identifier: FPColCOVIDReuma2020
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatic Diseases; Covid19

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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).

Drug: Disease-modifying antirheumatic drugs (DMARDs)

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).

Interventions

Disease-modifying antirheumatic drugs (DMARDs) DRUG

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

Exposed

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have a confirmed or suspected COVID-19 infection and have been treated at the Santa Fe de Bogotá University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

MeSH Terms

Conditions

Rheumatic Diseases; COVID-19

Interventions

Antirheumatic Agents

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 28, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: October 31, 2021
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share