Back to resultsImmunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome
Primary Purpose
Fatigue, Post-Acute COVID-19 Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Immunoadsorption vs. sham immunoadsorption
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue
Eligibility Criteria
Inclusion Criteria: 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. Exclusion citeria: 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 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
Sites / Locations
- Hannover Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Immunoadsorption
Sham immunoadsorption
Arm Description
5 immunoadsorption treatments
5 sham immunoadsorption treatments
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cognitive Function
Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment
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
Measure of health status
Evaluation of health status by Short Form Health Survey (SF-36)
Depression and Anxiety
Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)
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
6-min. walk test
Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test
Hand grip strength
Hand grip strength measured via digital hand dynamometer
Optical coherence tomography angiography
Assessment of retinal microcirculation
Cranial magnetic resonance imaging and spectroscopy
Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions
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
Neurocognitive function
Attentional deficits as assessed by Test of Attentional Performance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05954325
Brief Title
Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome
Official Title
Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Post-Acute COVID-19 Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded, randomized, sham-controlled trial
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunoadsorption
Arm Type
Experimental
Arm Description
5 immunoadsorption treatments
Arm Title
Sham immunoadsorption
Arm Type
Sham Comparator
Arm Description
5 sham immunoadsorption treatments
Intervention Type
Procedure
Intervention Name(s)
Immunoadsorption vs. sham immunoadsorption
Other Intervention Name(s)
Apheresis
Intervention Description
5 treatments within 14 days
Primary Outcome Measure Information:
Title
Chalder Fatigue Scale
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cognitive Function
Description
Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment
Time Frame
12 weeks
Title
Post exertional malaise symptoms
Description
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
Time Frame
12 weeks
Title
Measure of health status
Description
Evaluation of health status by Short Form Health Survey (SF-36)
Time Frame
12 weeks
Title
Depression and Anxiety
Description
Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
12 weeks
Title
Autonomic dysfunction
Description
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
Time Frame
12 weeks
Title
6-min. walk test
Description
Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test
Time Frame
12 weeks
Title
Hand grip strength
Description
Hand grip strength measured via digital hand dynamometer
Time Frame
12 weeks
Title
Optical coherence tomography angiography
Description
Assessment of retinal microcirculation
Time Frame
12 weeks
Title
Cranial magnetic resonance imaging and spectroscopy
Description
Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions
Time Frame
12 weeks
Title
Symptoms related to chronic fatigue before and after immunoadsorption
Description
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
Time Frame
12 weeks
Title
Neurocognitive function
Description
Attentional deficits as assessed by Test of Attentional Performance
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Safety and tolerability of immunoadsorption treatment
Description
Number of treatment emergent adverse events, serious adverse events and discontinuation due to treatment emergent adverse events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion citeria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Goedecke, MD
Phone
0049-511-532-0
Ext
3000
Email
studienzentrum@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Schmidt, MD
Phone
0049-511-532-0
Ext
3000
Email
studienzentrum@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Goedecke, MD
Organizational Affiliation
Hannover Medical School, Department of Nephrology and Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannover Medical School
Phone
0049-511-532-0
Ext
3000
Email
studienzentrum@mh-hannover.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome
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