COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04335747
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Salome Kristensen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Salome Kristensen, MD, PhD
Principal Investigator Affiliation Department of Rheumatology, Aalborg University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Systemic Lupus Erythematosus, Giant Cell Arteritis
Additional Details

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.

Arms & Interventions

Arms

: Group 1

Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection

: Group 2

Patients without inflammatory diseases who are hospitalised due to a 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

Interventions

Other: - COVID-19 infection

Hospitalisation due to a confirmed COVID-19 infection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aalborg University Hospital, Aalborg, Denmark

Status

Recruiting

Address

Aalborg University Hospital

Aalborg, , 9000

Site Contact

Line Uhrenholt, MD

[email protected]

+45 21707727

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