FatigueNCT05954325
Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome
A study of Fatigue and Post-Acute COVID-19 Syndrome, run by Hannover Medical School at 1 site in Germany.
Trial summary
The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatigue, Post-Acute COVID-19 Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Chronic Fatigue Syndrome (CFS) according to Canadian Consensus Criteria (at two time points > 4 weeks apart) with a duration of > 6 months with new onset < 12 weeks after PCR test confirmed SARS-CoV2-infection
- Chalder Fatigue Scale >/= 4 binary scale (at two time points > 4 weeks apart)
- Post exertional malaise >/= 14 h (at two time points > 4 weeks apart)
- Bell Scale 20-50 (at two time points > 4 weeks apart)
- Willing to comply with all aspects of the protocol, including blood draws, magnetic resonance imaging and ophthalmological evaluation
- Patient is able to understand and fully participate in the activities of the study and consent in accordance with guidelines
- Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period.
Who cannot join
- Chronic fatigue due to other medical or psychological condition
- Preexisting chronic fatigue prior to COVID infection
- Oxygen requirement or ventilation during acute phase of COVID
- Positive SARS-CoV-2-PCR test at the beginning of the study
- Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others: malignant disease within the last 5 years, moderate to severe renal impairment (eGFR <60 ml/min), cardiac insufficiency (LVEF <40%), severe coronary heart disease, severe hypercoagulability
- Acute or severe psychiatric disease
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- Active/acute infectious diseases like CMV, EBV, HBV, HCV, HIV, TBC
- Patients who in the investigator's opinion might not be suitable for study (difficult peripheral venous access, not able to complete questionnaires e.g. due to language problems)
- Taking immunosuppressive medication >3 weeks within 12 months before study inclusion
- Any apheresis therapy before study inclusion
- Contraindications for magnetic resonance imaging
- Patients revealing abnormal brain structures visible in MR images
- Patients with pre-existing ophthalmological condition or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. There is increasing evidence that a dysregulated post-viral immune response may be involved in the pathogenesis of post COVID syndrome. In uncontrolled case studies, an improvement of fatigue symptoms after removing autoantibodies has been reported in post COVID patients. However, there is a lack of prospective, sham controlled studies. We initiate an interventional, randomised, sham treatment-controlled prospective study, the EXTINCT post COVID study, which aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome.
- Conditions
- Fatigue, Post-Acute COVID-19 Syndrome
- Being tested
- Immunoadsorption vs. sham immunoadsorption
- Keywords
- Post COVID syndrome, Fatigue, Immunoadsorption
- Medical subject headings
- Fatigue, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoadsorption vs. sham immunoadsorptionProcedure or surgery
Also called Apheresis
5 treatments within 14 days
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption | Experimental | 5 immunoadsorption treatments Receives: Procedure: Immunoadsorption vs. sham immunoadsorption |
| Sham immunoadsorption | Sham comparator | 5 sham immunoadsorption treatments Receives: Procedure: Immunoadsorption vs. sham immunoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chalder Fatigue Scale
Time course of fatigue symptoms as determined based on Chalder Fatigue Scale (ranging from 0 to 33), higher values indicating a higher burden of fatigue symptoms
Measured: 12 weeks
Secondary outcomes (11)
Cognitive Function
Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment
Measured: 12 weeks
Post exertional malaise symptoms
Assessment of frequency and severity of post exertional malaise symptoms (frequency: 0-20, severity: 0-20, duration), higher values indicating a higher burden of post exertional malaise symptoms
Measured: 12 weeks
Measure of health status
Evaluation of health status by Short Form Health Survey (SF-36)
Measured: 12 weeks
Depression and Anxiety
Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 12 weeks
Autonomic dysfunction
Symptoms of autonomic dysfunction assessed by Composite Autonomic Symptom Score (COMPASS 31), generating a weighted score from 0 to 100, with higher scores representing higher symptom burden
Measured: 12 weeks
6-min. walk test
Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test
Measured: 12 weeks
Hand grip strength
Hand grip strength measured via digital hand dynamometer
Measured: 12 weeks
Optical coherence tomography angiography
Assessment of retinal microcirculation
Measured: 12 weeks
Cranial magnetic resonance imaging and spectroscopy
Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions
Measured: 12 weeks
Symptoms related to chronic fatigue before and after immunoadsorption
Change of symptoms as measured by Fluge score, using a scale ranging from 1 to 10 (higher values representing higher symptom load) assessing 32 fatigue related symptoms and their intra-patient change from baseline to follow-up
Measured: 12 weeks
Neurocognitive function
Attentional deficits as assessed by Test of Attentional Performance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start15 Aug 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Goedecke, MD, Principal investigator, Hannover Medical School, Department of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954325
- Sponsor's protocol ID
- EXTINCT post COVID
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05954325
- Acronym / sponsor ID
- EXTINCT post COVID
- Conditions
- Fatigue, Post-Acute COVID-19 Syndrome
- Keywords
- Post COVID syndrome, Fatigue, Immunoadsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. There is increasing evidence that a dysregulated post-viral immune response may be involved in the pathogenesis of post COVID syndrome. In uncontrolled case studies, an improvement of fatigue symptoms after removing autoantibodies has been reported in post COVID patients. However, there is a lack of prospective, sham controlled studies. We initiate an interventional, randomised, sham treatment-controlled prospective study, the EXTINCT post COVID study, which aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomized, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption | Experimental | Procedure: Immunoadsorption vs. sham immunoadsorption5 immunoadsorption treatments |
| Sham immunoadsorption | Sham comparator | Procedure: Immunoadsorption vs. sham immunoadsorption5 sham immunoadsorption treatments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years
- Chronic Fatigue Syndrome (CFS) according to Canadian Consensus Criteria (at two time points > 4 weeks apart) with a duration of > 6 months with new onset < 12 weeks after PCR test confirmed SARS-CoV2-infection
- Chalder Fatigue Scale >/= 4 binary scale (at two time points > 4 weeks apart)
- Post exertional malaise >/= 14 h (at two time points > 4 weeks apart)
- Bell Scale 20-50 (at two time points > 4 weeks apart)
Key exclusion criteria (13 listed)
- Chronic fatigue due to other medical or psychological condition
- Preexisting chronic fatigue prior to COVID infection
- Oxygen requirement or ventilation during acute phase of COVID
- Positive SARS-CoV-2-PCR test at the beginning of the study
- Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others: malignant disease within the last 5 years, moderate to severe renal impairment (eGFR <60 ml/min), cardiac insufficiency (LVEF <40%), severe coronary heart disease, severe hypercoagulability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoadsorption vs. sham immunoadsorptionAlso: Apheresis5 treatments within 14 days | Procedure or surgery | Immunoadsorption, Sham immunoadsorption |
Primary outcome
Chalder Fatigue Scale
Time frame: 12 weeks
Time course of fatigue symptoms as determined based on Chalder Fatigue Scale (ranging from 0 to 33), higher values indicating a higher burden of fatigue symptoms
11 secondary outcomes
Cognitive Function
Time frame: 12 weeks
Post exertional malaise symptoms
Time frame: 12 weeks
Measure of health status
Time frame: 12 weeks
Depression and Anxiety
Time frame: 12 weeks
Autonomic dysfunction
Time frame: 12 weeks
6-min. walk test
Time frame: 12 weeks
Hand grip strength
Time frame: 12 weeks
Optical coherence tomography angiography
Time frame: 12 weeks
Cranial magnetic resonance imaging and spectroscopy
Time frame: 12 weeks
Symptoms related to chronic fatigue before and after immunoadsorption
Time frame: 12 weeks
Neurocognitive function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Goedecke, MD principal investigator
Hannover Medical School, Department of Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fatigue and Post-Acute COVID-19 Syndrome, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chalder Fatigue Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.