Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis Systemic Lupus Erythematosus Giant Cell Arteritis Other: COVID-19 infection

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 333 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : September 1, 2021


Group/Cohort Intervention/treatment
Group 1
Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection
Other: COVID-19 infection
Hospitalisation due to a confirmed COVID-19 infection

Group 2
Patients without inflammatory diseases who are hospitalised due to a COVID-19 infection
Other: COVID-19 infection
Hospitalisation due to a confirmed 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335747


Contacts
Layout table for location contacts
Contact: Line Uhrenholt, MD +45 21707727 l.uhrenholt@rn.dk
Contact: Salome Kristensen, MD, PhD

Locations
Layout table for location information
Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Line Uhrenholt, MD    +45 21707727    l.uhrenholt@rn.dk   
Contact: Salome Kristensen, MD, PhD       sakr@rn.dk   
Sponsors and Collaborators
Salome Kristensen
Investigators
Layout table for investigator information
Principal Investigator: Salome Kristensen, MD, PhD Department of Rheumatology, Aalborg University Hospital
Layout table for additonal information
Responsible Party: Salome Kristensen, MD, PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04335747    
Other Study ID Numbers: 20200401
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Rheumatic Diseases
Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Lupus Erythematosus, Systemic
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases