Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases (CovAID)

August 27, 2021 updated by: Assistance Publique - Hôpitaux de Paris
Factors associated with severe forms of COVID-19 infection in patients with inflammatory rheumatic diseases (IRD) or Autoimmune Diseases (AID) are unknown. This unprecedented situation leads to empirical and potentially erroneous advice and recommendations for care. Identifying factors associated with severity, in the context of this pandemic, which is expected to last many months, and possibly years, is crucial for future patients. The objective of this work is to identify the factors associated with the occurrence of severe forms of COVID-19 infection in patients with IRD or AID, by combining analysis of 2 large databases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory diseases (Rheumatoid arthritis, Spondyloarthritis, Psoriatic arthritis Lupus, Sjögren's syndrome, Inflammatory Myositis, Systemic Vasculitis, Sarcoidosis, Scleroderma, PPR/Horton's, other ...) with confirmed SARS-Cov-2 infection (COVID-19) whose data are available in the APHP health data center (EDS) or in the french RMD Covid19 cohort

Description

Inclusion Criteria:

  • Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory diseases (Rheumatoid arthritis, Spondyloarthritis, Psoriatic arthritis Lupus, Sjögren's syndrome, Inflammatory Myositis, Systemic Vasculitis, Sarcoidosis, Scleroderma, PPR/Horton's, other ...)
  • At least 18 years old
  • SARS-Cov-2 infection (COVID-19) by biological data (serological or positive Cov-2 PCR) or CT scan images or clinical observations consistent with covid-19 between January 2020 and September 2020
  • data available in the APHP health data center (EDS) or in the french RMD Covid19 cohort

Exclusion Criteria:

  • patients opposed to the use of their data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
moderate to severe
patients with known inflammatory rheumatism, auto-immune or auto-inflammatory diseases (as define in the inclusion criteria) with moderate to severe or severe form of covid-19
Other: no intervention
no intervention, only collection of data
begining to moderate
Patients with known inflammatory rheumatism, auto-immune or auto-inflammatory diseases (as define in the inclusion criteria) with begnin to moderate or moderate form of covid-19
Other: no intervention
no intervention, only collection of data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
risk factors associated with severity
Time Frame: during covid infection
Between begining to moderate and moderate to severe group: Severe form is defined by be defined by hospitalization in intensive care unit and/or death. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed.
during covid infection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
risk factors associated with severe form
Time Frame: during covid infection
in moderate to severe group: Moderate to severe form is defined by be defined by hospitalization for COVID infection. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed. Pooled analysed and Analyses by IRD/AID subset will be performed, since prognosis might differ in the different diseases : IRD (including rheumatoid arthritis and spondyloarthritis), other AID, and systemic vaculitis)
during covid infection
risk factors associated with severe form
Time Frame: during covid infection
in severe group only: Severe form is defined by be defined by hospitalization in intensive care unit and/or death. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed. Analyses by IRD/AID subset will be performed, since prognosis might differ in the different diseases : IRD (including rheumatoid arthritis and spondyloarthritis), other AID, and systemic vaculitis)
during covid infection
risk factors associated with death
Time Frame: during covid infection
Death during COVID-19 infection. Demographic, Comorbidities (and their treatments), underlying IRD and AID and treatments for IRD or AID will be analysed. Pooled analysed and Analyses by IRD/AID subset will be performed, since prognosis might differ in the different diseases : IRD (including rheumatoid arthritis and spondyloarthritis), other AID, and systemic vaculitis)
during covid infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP200714

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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