SARS-CoV2 InfectionCovAIDNCT05026892
Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases
An observational study of SARS-CoV2 Infection and Rare Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV2 Infection, Rare Diseases, Chronic Inflammatory Rheumatism
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2021to Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- patients opposed to the use of their data
Trial locations and contacts
1 site in 1 country.
France1 site
Bicêtre Hospital
Le Kremlin-Bicêtre, 94270
Raphaele SEROR, Pr, 01 45 21 37 59 ext. +33, raphaele.seror@aphp.fr
About this study
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.
- Being tested
- no intervention
- Keywords
- SARS-CoV2 Infection, Rare Diseases, Chronic Inflammatory Rheumatism, Autoimmune Diseases, auto-inflammatory diseases
- Medical subject headings
- COVID-19, Rare Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, only collection of data
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: no intervention | |
| 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 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk factors associated with severity
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.
Measured: during covid infection
Secondary outcomes (3)
risk factors associated with severe form
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)
Measured: during covid infection
risk factors associated with severe form
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)
Measured: during covid infection
risk factors associated with death
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)
Measured: during covid infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026892
- Sponsor's protocol ID
- APHP200714
- Acronym
- CovAID
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT05026892
- Acronym / sponsor ID
- CovAID / APHP200714
- Keywords
- SARS-CoV2 Infection, Rare Diseases, Chronic Inflammatory Rheumatism, Autoimmune Diseases, auto-inflammatory diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 30 Aug 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate to severe | – | Other: no interventionpatients 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 |
| begining to moderate | – | Other: no interventionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- patients opposed to the use of their data
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 |
|---|---|---|
| no interventionno intervention, only collection of data | Other | begining to moderate, moderate to severe |
Primary outcome
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.
3 secondary outcomes
risk factors associated with severe form
Time frame: during covid infection
risk factors associated with severe form
Time frame: during covid infection
risk factors associated with death
Time frame: during covid infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection and Rare Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Raphaele SEROR, Pr (01 45 21 37 59 ext. +33, raphaele.seror@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk factors associated with severity (time frame: during covid infection). 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 30 Aug 2021.