Primary Objective: Identifying the auto-antigens that cause long-COVID symptoms Secondary Objective(s): Isolate and sequence the auto-reactive B cells to produce recombinant long-COVID autoantibodies
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Post-infectioeuze ziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome parameters for autoantibody analysis by HuProt will be the presence of
autoantibodies that are unique for the long-COVID patients in venous blood
Secondary outcome
The binding of the recombinant antibodies to the antigens that we identified by
HuProt analysis
Background summary
About 10-30% of COVID*19 survivors develop long*COVID, indicating a substantial
and long-lasting personal and societal impact of this disease at a worldwide
level. In our preliminary work, we have identified autoimmunity as a cause of
long-COVID.
Yet, it remains unknown whether the induced auto-antibodies are innocent
bystanders, or whether they really cause (or amplify) long-COVID symptoms. In
order to validate the earlier found auto-antigens and to isolate the
responsible B cells to recombinant produce the disease-causing IgG
autoantibodies, subsequent longitudinal measurements needs to be analyzed.
Study objective
Primary Objective: Identifying the auto-antigens that cause long-COVID symptoms
Secondary Objective(s): Isolate and sequence the auto-reactive B cells to
produce recombinant long-COVID autoantibodies
Study design
This study will obtain venous blood at one single time point. The estimated
time of a visit will be approximately one hour. For this study all 34 Long
Covid patients will be contacted again to confirm and validate earlier found
possible auto-antigens, which could be the cause of Long COVID. With this
validation sample it will be possible to predict more accurately which
auto-antibodies are responsible for the Long Covid symptoms. The minimal time
between the initial blood draw and the still to be performed second blood draw
will be three months.
All Long-Covid patients have an informed consent to be contacted for future
research throughout the Amsterdam UMC post-COVID-19 biobank. Many of the
Long-Covid patients from the outpatient clinic have shown great interest in
additional research and therefore we expect no problem to recruit all
participants
3.2 Inclusion criteria
In order to be eligible to participate in this study, a Long-Covid patient must
meet all of the following criteria:
* Non-hospitalized individuals with prior confirmed diagnosis of severe acute
respiratory coronavirus 2 (SARS-CoV-2) infection by reverse
transcription-polymerase chain reaction testing or serology (wantai) testing
* No Long-Covid symptoms present before confirmed diagnosis of SARS-CoV-2
* Individuals with diagnosed PASC by an Amsterdam UMC post-covid physician
* Aged between 18-65 years
3.3 Exclusion criteria
* Pregnancy
* Chronic illness
Study burden and risks
Low risk
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Non-hospitalized individuals with prior confirmed diagnosis of severe acute
respiratory coronavirus 2 (SARS-CoV-2) infection by reverse
transcription-polymerase chain reaction testing or serology (wantai) testing
* No Long-Covid symptoms present before confirmed diagnosis of SARS-CoV-2
* Individuals with diagnosed PASC by an Amsterdam UMC post-covid physician
* Aged between 18-65 years
Exclusion criteria
* Pregnancy
* Chronic illness (including orthopaedic, endocrinological, haematological,
malignant, gastrointestinal, neurological, muscle or inflammatory disorders)
likely to significantly impact on exercise performance
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 | NL83733.018.23 |