coronavirus COVID-19
Conditions
Interventions
None listed
Sponsors
Reade
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For patients: - Older than 18; - Diagnosed by their treating physician with a inflammatory chronic disease. For controls: - Family or close friend of an eligible patient (preferably of the same gender).
Exclusion criteria
Exclusion criteria: - Language problems precluding the completion of the questionnaire; - Likelihood of absence in the next 6 months; - Lack of informed consent. For controls: - Age difference with matched patient > 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective will be to compare the disease severity of COVID-19 between patients with a chronic inflammatory and a control population. Disease severity is defined as the (unplanned) hospital admission rate of participants that are both IgM- or IgG-SARS-CoV-2 antibody positive and symptomatic. Symptomatic is defined as symptoms or signs of nasopharyngitis, cough, dyspnea, fever, or any other symptom or sign that may be associated with a viral infection, as assessed by the patient. Unplanned refers to the fact that elective hospital admissions (e.g., for planned surgery) are excluded. | — |
Secondary
| Measure | Time frame |
|---|---|
| One of the secondary objectives is to study the following differences between patients and controls, and subsequently, within the inflammatory disease group, between conventional DMARDs (including glucocorticoid) users and biologics users, in: - Cumulative (6-month) incidence of IgM or IgG antibodies against SARS-CoV-2; - Disease severity of hospitalized COVID-19 patients (defined as ICU admission or death); - Antibody profile (IgM/G/A, IgG1/3) and repertoire (anti-SP, anti-NP), and IgG antibody avidity. We will also investigate whether physicians and/or patients decide to adjust the use or dose of immunosuppressive medication due to the SARS-CoV-2 pandemic, and how these potential adjustments influence disease activity. An addendum has been added to the protocol with additional secundary endpoints for the SLE population. In this population, the role of PI3 kinase (PI3K) signalling will be investigated. Also, we will evaluate whether an increased expression of type I interferon regulated genes is associated with the reaction to COVID-19. | — |
Countries
Netherlands
Outcome results
None listed