- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567576
Predictive Factors for COVID-19 in Rheumatology
Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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):
|
1-12 weeks
|
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 |
1-12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- COVID-19
- Rheumatic Diseases
- Collagen Diseases
- Antirheumatic Agents
Other Study ID Numbers
- FPColCOVIDReuma2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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