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COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

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ClinicalTrials.gov Identifier: NCT04335747
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Salome Kristensen, Aalborg University Hospital

Tracking Information
First Submitted Date April 3, 2020
First Posted Date April 6, 2020
Last Update Posted Date May 29, 2020
Actual Study Start Date April 23, 2020
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2020)
Disease activity [ Time Frame: Last registration of disease activity in the medical journal before admission/inclusion ]
The objective is to examine whether increased disease activity leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 3, 2020)
  • Immune modulating treatments [ Time Frame: Current immune modulating treatments at admission/inclusion ]
    Examine whether immune modulating treatments protect or leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease.
  • Biomarkers [ Time Frame: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1 ]
    Identify prognostic biomarkers by comparing serology of patients with inflammatory rheumatic disease hospitalized with COVID-19 and comparing them with the two control groups
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Official Title COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Brief Summary The trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups.
Detailed Description

The pandemic caused by the coronavirus, SARS-CoV-19, has severely affected health care systems around the world. In Denmark, more than 85,000 patients have a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE), or giant cell arthritis, and many are treated with immunosuppressive therapy including biologics.

At present it is unclear whether the best course of action during a viral pandemic is to pause treatment with biologics, change to drugs with a different mode of action or continue treatment as usual.

Many patients with RA and SLE receive hydroxychloroquine (HCL) treatment for their rheumatic disease, but HCL has also been suggested as a potential treatment for COVID-19 infection.

This trial aim to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation, including IL6 and IL10 in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with measures in control groups.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population Groups 1 and 2: admitted patients with a COVID-19 infection at Aalborg University Hospital Group 3: the Rheumatology Outpatient Clinic at Aalborg University Hospital Group 4: the Blood Bank for Danish Blood Donors at Aalborg University Hospital
Condition
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Axial Spondyloarthritis
  • Systemic Lupus Erythematosus
  • Giant Cell Arteritis
Intervention Other: COVID-19 infection
Hospitalisation due to a confirmed COVID-19 infection
Study Groups/Cohorts
  • Group 1
    Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection
    Intervention: Other: COVID-19 infection
  • Group 2
    Patients without inflammatory diseases who are hospitalised due to a COVID-19 infection
    Intervention: Other: COVID-19 infection
  • Group 3
    Patients with inflammatory rheumatic diseases who are having routine blood samples taken under the COVID-19 epidemic after inclusion and who have NOT been hospitalised due to a COVID-19 infection
  • Group 4
    Healthy subjects from the Danish Blood Donors have NOT been hospitalised due to a COVID-19 infection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 3, 2020)
333
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Group 1:

  • Diagnosed with RA, PsA, axSpA, SLE or AT and currently treated with either conventional synthetic disease modifying antirheumatic drugs (csDMARDs), biologic disease modifying antirheumatic drugs (bDMARDs), targeted synthetic disease modifying antirheumatic drugs (tsDMARDs) or prednisolone.
  • Diagnosed with COVID-19 verified by Polymerase Chain Reaction (PCR) or other accepted methods and hospitalized.
  • NOT diagnosed with disease known to cause either immunodeficiency or modification (Human Immunodeficiency Virus [HIV], lymphoproliferative disease etc.).
  • Patients (≥18 years).
  • Ability and willingness to give written informed consent.
  • Ability to cooperate with research staff.

Group 2:

  • NOT diagnosed with an inflammatory disease
  • NOT treated with either csDMARDs, bDMARDs, tsDMARDs during the past 6 months or current oral prednisolone treatment.
  • Diagnosed with COVID-19 verified by PCR or other accepted methods and hospitalized.
  • NOT diagnosed with disease known to cause either immunodeficiency or modification (HIV, lymphoproliferative disease etc.).
  • Patients (≥18 years).
  • Ability and willingness to give written informed consent.
  • Ability to cooperate with research staff.

Group 3:

  • Diagnosed with RA, PsA, axSpA, SLE or AT and currently treated with either csDMARDs, bDMARDs, tsDMARDs or prednisolone.
  • NOT hospitalised due to a COVID-19 infection.
  • NOT diagnosed with disease known to cause either immunodeficiency or modification (HIV, lymphoproliferative disease etc.).
  • Patients (≥18 years).
  • Ability and willingness to give written informed consent.
  • Ability to cooperate with research staff.

Group 4:

  • Healthy subjects from the Danish Blood Donors.
  • Patients (≥18 years).
  • NOT diagnosed with an inflammatory disease.
  • NOT treated with either csDMARDs, bDMARDs, tsDMARDs during the past 6 months or current oral prednisolone treatment.
  • NOT hospitalised due to a COVID-19 infection.
  • Ability and willingness to give written informed consent.
  • Ability to cooperate with research staff.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Line Uhrenholt, MD +45 21707727 l.uhrenholt@rn.dk
Contact: Salome Kristensen, MD, PhD
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04335747
Other Study ID Numbers 20200401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Salome Kristensen, Aalborg University Hospital
Study Sponsor Salome Kristensen
Collaborators Not Provided
Investigators
Principal Investigator: Salome Kristensen, MD, PhD Department of Rheumatology, Aalborg University Hospital
PRS Account Aalborg University Hospital
Verification Date May 2020