💬In plain words
What the trial is, and whether it could suit you
Some people report persistent health problems after receiving the COVID-19 vaccine. These symptoms persist well beyond typical short-term vaccine side effects and are not attributable to any other known medical conditions. This condition is known as Post-Acute COVID-19 Vaccination Syndrome (PACVS). Symptoms can persist for months and affect several organ systems, causing issues such as fatigue, heart-related problems, neurological difficulties, and decreases in both physical ability and mental performance. PACVS shows similarities to Post-Acute COVID-19 syndrome (PACS) and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
The biological processes that cause PACVS are still not fully understood. Recent research indicates that endothelial dysfunction, abnormalities in blood coagulation, and persistent inflammatory responses may contribute significantly to this process. However,
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
General Criteria (apply to all study parts: PROGRESS, ENDOCLOT, REAL, patients and matched healthy controls)
Inclusion Criteria
1. Age ≥ 18 years
2. Sufficient knowledge of German to complete study-related questionnaires and procedures
Exclusion Criteria
1. Severe cognitive, physical impairment or psychiatric conditions impeding participation
2. Active oncological disease or immunosuppressive
3. Known pregnancy at the time of enrolment
PROGRESS (patients only)
Inclusion Criteria
1. Coded participation with online consent confirmation
2. Self-reported onset of persistent symptoms temporally associated with a COVID-19 vaccination
3. Willingness and ability to participate in the 8-month follow-up period
Exclusion Criteria
1\. No specific exclusion criteria for this part
ENDOCLOT and REAL (patients and matched healthy controls)
Inclusion Criteria
1. Signed informed consent form
2. For patients:
1. Receipt of at least one COVID-19 vaccination
2. Onset of new, otherwise unexplained symptoms within 0-14 days after vaccination
3. Persistence of symptoms for at least 6 months following vaccination
4. Selection is based on a diagnosis of ME/CFS according to the Canadian Consensus Criteria (CCC) and PEM.
2\. For controls: History of COVID-19 vaccination without persistent adverse effects; age (+/- 10 years), and sex match to a corresponding case
Exclusion Criteria (patients and matched healthy controls)
1. Clinically suspected or laboratory confirmed SARS-CoV-2 infection after vaccination or temporally related to symptom onset.
2. Concurrent pre-existing Long COVID symptoms, obtained from the patient´s history
3. Any self-reported or uncertain history of an acute infectious event (including mild or subclinical infections) in temporal proximity to COVID-19 vaccination
4. Known pre-existing medical conditions or ongoing medications that could plausibly explain the reported symptoms (e.g., preexisting ME/CFS, POTS, fibromyalgia, small-fiberneuropathy, autoimmune disease with systemic involvement or other chronic multisystemic dysautonomia syndromes)
5. Use of long-term, high-dose anti-inflammatory
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