Rheumatic DiseasesNCT04567576
Predictive Factors for COVID-19 in Rheumatology
An observational study of Rheumatic Diseases and Covid19, run by Fundación Santa Fe de Bogota.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatic Diseases, Covid19
- What is being tested?
- Disease-modifying antirheumatic drugs (DMARDs)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a confirmed or suspected COVID-19 infection and have been treated at the Santa Fe de Bogotá University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance
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.
Read the 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.
- Conditions
- Rheumatic Diseases, Covid19
- Being tested
- Disease-modifying antirheumatic drugs (DMARDs)
- Medical subject headings
- Rheumatic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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? →
- 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
Measured: 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?
- Yes, he passed away
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Maldonado Cañón, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567576
- Sponsor's protocol ID
- FPColCOVIDReuma2020
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance
- ClinicalTrials.gov ID
- NCT04567576
- Acronym / sponsor ID
- FPColCOVIDReuma2020
- Conditions
- Rheumatic Diseases, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Drug: 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). |
| 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a confirmed or suspected COVID-19 infection and have been treated at the Santa Fe de Bogotá University Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease-modifying antirheumatic drugs (DMARDs)Within a non-experimental setting, the routine disease-modifying antirheumatic drugs (DMARDs) prescription will be evaluated as the "exposure". | Drug | Exposed |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Covid19, run by Fundación Santa Fe de Bogota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical behavior of the disease // COVID-19 (time frame: 1-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.