Covid19ProCOVRANCT04679272
Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients
An observational study of Covid19 and Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Rheumatoid Arthritis
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 1 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population description: * * Patients with RA, included in the French RMD Covid-19 cohort, with a confirmed COVID-19 diagnosis (positive PCR or serology). * Patients included in the Montpellier COVID-19 cohort, without autoimmune disease or inflammatory rheumatism, and with a confirmed COVID-19 diagnosis (positive PCR or serology).
Who may be able to join
- Confirmed COVID-19 diagnosis (positive PCR or serology) in RA patients or healthy controls.
Who cannot join
- Age under 18 years old
- Suspected COVID-19 diagnosis (typical symptoms without a positive PCR or serology)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA
COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.
- Conditions
- Covid19, Rheumatoid Arthritis
- Keywords
- DMARDs, Biotherapy
- Medical subject headings
- COVID-19, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rates for COVID-19
Proportion of hospitalized patients in RA group or control group. From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Secondary outcomes (6)
Critical care transfer rate for COVID-19 and death due to COVID-19
Proportion of patients transferred in critical care for COVID-19 or deaths due to COVID-19 From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Pulmonary comorbidities, corticosteroids or DMARDs use
Type and severity of patients pulmonary comorbidities and treatment by corticosteroids or DMARDs in RA group From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Age
Patients demographics From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Number of Participants with co-morbidities
Patients comorbidities From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Type of clinical presentation
Patients COVID-19 clinical presentation From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Type of associated treatments
From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Padern Guillaume, physician, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679272
- Sponsor's protocol ID
- RECHMPL20_0682
- Acronym
- ProCOVRA
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA
- ClinicalTrials.gov ID
- NCT04679272
- Acronym / sponsor ID
- ProCOVRA / RECHMPL20_0682
- Conditions
- Covid19, Rheumatoid Arthritis
- Keywords
- DMARDs, Biotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 22 Dec 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.
COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population description: * * Patients with RA, included in the French RMD Covid-19 cohort, with a confirmed COVID-19 diagnosis (positive PCR or serology). * Patients included in the Montpellier COVID-19 cohort, without autoimmune disease or inflammatory rheumatism, and with a confirmed COVID-19 diagnosis (positive PCR or serology).
Key inclusion criteria (1 listed)
- Confirmed COVID-19 diagnosis (positive PCR or serology) in RA patients or healthy controls.
Key exclusion criteria (2 listed)
- Age under 18 years old
- Suspected COVID-19 diagnosis (typical symptoms without a positive PCR or serology)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalization rates for COVID-19
Time frame: 1 day
Proportion of hospitalized patients in RA group or control group. From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
6 secondary outcomes
Critical care transfer rate for COVID-19 and death due to COVID-19
Time frame: 1 day
Pulmonary comorbidities, corticosteroids or DMARDs use
Time frame: 1 day
Age
Time frame: 1 day
Number of Participants with co-morbidities
Time frame: 1 day
Type of clinical presentation
Time frame: 1 day
Type of associated treatments
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Padern Guillaume, physician principal investigator
University Hospitals of Montpellier
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 Covid19 and Rheumatoid Arthritis, run by University Hospital, Montpellier 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospitalization rates for COVID-19 (time frame: 1 day). 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 1 Mar 2021.