The primary objective will focus on both the difference in incidence and disease severity of COVID-19 between patients with a chronic inflammatory disease and the control group.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In December 2019 the first case of COVID-19 was identified in China. In the
months thereafter the number of laboratory confirmed cases exponentially
increased around the world. The World Health Organization has officially
declared the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a
public health emergency of international concern and more recently a pandemic.
Although some studies focused on identifying the risk factors for disease
severity, none of these studies have investigated the use of immunosuppressive
medication and its influence on disease severity and antibody response.
A large proportion of patients with a chronic inflammatory disease are being
treated with immunosuppressive medication. In previous studies
immunosuppressive medication have been associated with an increased risk for
serious infections. However, none of the previous research has specifically
focused on the influence of immunosuppressive medication on viral infections in
terms of disease severity or antibody response. With the emergence of the
SARS-CoV-2 there is the unique opportunity to study these questions. This group
of patients is extra interesting since a proportion of patients with rheumatic
diseases is treated with hydroxychloroquine and tocilizumab. Recent studies
indicate that tocilizumab reduces the likelihood of progression to mechanical
ventilation or death in hospitalized patients with COVID-19. For
hydroxychloroquine, which has recently been identified to have in vitro
antiviral properties, no protective effects have been demonstrated. However,
studies investigating prophylactic effects of tocilizumab and
hydroxychloroquine have not yet been performed. It would therefore be
interesting to study disease severity and the antibody response in this
specific category of patients.
In addition, multiple variants of SARS-CoV-2 with varying pathogenicity and
transmissibility have circulated through society. It is expected that
SARS-CoV-2 will continue to evolve into new variants and impact society,
possibly causing endemics. The vast majority of people, including patients with
chronic inflammatory diseases, have developed immunity against SARS-CoV-2,
either via vaccination, infection or both. However, data on long-term
protection against SARS-CoV-2 in patients with chronic inflammatory diseases
are still lacking, which emphasizes the importance of studies with longer
follow-up.
Lastly, recent studies have shown that SARS-CoV-2 infections can cause
longstanding symptoms that have a negative impact on daily functioning and
quality of life, even when the disease course was mild. This phenomenon is
called post-COVID syndrome or long COVID. However, data on the prevalence,
disease course and impact of long COVID on patients with chronic inflammatory
diseases are still scarce. Studies with longer follow-up are necessary to
investigate this, which can help in providing information to and improve
guidance of patients with chronic inflammatory diseases.
Study objective
The primary objective will focus on both the difference in incidence and
disease severity of COVID-19 between patients with a chronic inflammatory
disease and the control group.
Study design
This is a prospective observational cohort study with a follow-up of 18 months.
The baseline measurement will consist of a digital survey covering demographic
variables, specific health-related topics, and COVID-19 relevant questions.
Subjects will be asked to fill in the same survey after 1-3, 4-6, 7-9, 10-12,
13-15 and 16-18 months of follow-up, and 2-4 times per year during the next 5
years of follow-up. In addition, during follow-up blood will be drawn up to
fourteen times within approximately one week of completion of an online survey.
Patients with a chronic inflammatory disease will be asked, but not obliged, to
complete additional questionnaires regarding disease activity and to draw
additional blood in case of a flare.
Study burden and risks
Risks associated with participation in this study are very low. The research
burden consists of the following: all subjects will be asked to complete the
online survey 17-27 times. This survey covers several subjects, among which
respiratory illnesses (including hospital and or ICU admittance), rheumatic
disease activity and medication use. Demographic data will also be collected at
baseline. In addition, blood will be drawn after 1-3, 4-6, 7-14 and 16-18
months of follow up, and up to twice per year during the next 5 years of
follow-up. Patients with a chronic inflammatory disease will be asked, but not
obliged, to complete additional questionnaires regarding disease activity and
to draw additional blood in case of a flare.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73521.029.20 |
| Other | NL8513 |