Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictive Factors for COVID-19 in Rheumatology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567576
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Kevin Maldonado Cañón, 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.

Condition or disease Intervention/treatment
Rheumatic Diseases Covid19 Drug: Disease-modifying antirheumatic drugs (DMARDs)

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : October 31, 2021

Group/Cohort Intervention/treatment
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)
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).



Primary Outcome Measures :
  1. Clinical behavior of the disease // COVID-19 [ Time Frame: 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

  2. Mortality [ Time Frame: 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Layout table for additonal information
Responsible Party: Kevin Maldonado Cañón, Research Assistant, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier: NCT04567576    
Other Study ID Numbers: FPColCOVIDReuma2020
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Antirheumatic Agents