The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05954325
Recruitment Status : Recruiting
First Posted : July 20, 2023
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Fatigue Post-Acute COVID-19 Syndrome Procedure: Immunoadsorption vs. sham immunoadsorption Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, randomized, sham-controlled trial
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Immunoadsorption
5 immunoadsorption treatments
 Procedure: Immunoadsorption vs. sham immunoadsorption
5 treatments within 14 days
Other Name: Apheresis
Sham Comparator: Sham immunoadsorption
5 sham immunoadsorption treatments
 Procedure: Immunoadsorption vs. sham immunoadsorption
5 treatments within 14 days
Other Name: Apheresis


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: 12 weeks ]
    Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment

  2. Post exertional malaise symptoms [ Time Frame: 12 weeks ]
    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

  3. Measure of health status [ Time Frame: 12 weeks ]
    Evaluation of health status by Short Form Health Survey (SF-36)

  4. Depression and Anxiety [ Time Frame: 12 weeks ]
    Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)

  5. Autonomic dysfunction [ Time Frame: 12 weeks ]
    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. 6-min. walk test [ Time Frame: 12 weeks ]
    Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test

  7. Hand grip strength [ Time Frame: 12 weeks ]
    Hand grip strength measured via digital hand dynamometer

  8. Optical coherence tomography angiography [ Time Frame: 12 weeks ]
    Assessment of retinal microcirculation

  9. Cranial magnetic resonance imaging and spectroscopy [ Time Frame: 12 weeks ]
    Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions

  10. Symptoms related to chronic fatigue before and after immunoadsorption [ Time Frame: 12 weeks ]
    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

  11. Neurocognitive function [ Time Frame: 12 weeks ]
    Attentional deficits as assessed by Test of Attentional Performance


Other Outcome Measures:
  1. Safety and tolerability of immunoadsorption treatment [ Time Frame: 12 weeks ]
    Number of treatment emergent adverse events, serious adverse events and discontinuation due to treatment emergent adverse events


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years
  2. 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
  3. Chalder Fatigue Scale >/= 4 binary scale (at two time points > 4 weeks apart)
  4. Post exertional malaise >/= 14 h (at two time points > 4 weeks apart)
  5. Bell Scale 20-50 (at two time points > 4 weeks apart)
  6. Willing to comply with all aspects of the protocol, including blood draws, magnetic resonance imaging and ophthalmological evaluation
  7. Patient is able to understand and fully participate in the activities of the study and consent in accordance with guidelines
  8. 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:

  1. Chronic fatigue due to other medical or psychological condition
  2. Preexisting chronic fatigue prior to COVID infection
  3. Oxygen requirement or ventilation during acute phase of COVID
  4. Positive SARS-CoV-2-PCR test at the beginning of the study
  5. 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
  6. Acute or severe psychiatric disease
  7. Active/acute infectious diseases like CMV, EBV, HBV, HCV, HIV, TBC
  8. 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)
  9. Taking immunosuppressive medication >3 weeks within 12 months before study inclusion
  10. Any apheresis therapy before study inclusion
  11. Contraindications for magnetic resonance imaging
  12. Patients revealing abnormal brain structures visible in MR images
  13. Patients with pre-existing ophthalmological condition or diabetes mellitus
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05954325


Contacts
Layout table for location contacts
Contact: Dr. Goedecke, MD 0049-511-532-0 ext 3000 studienzentrum@mh-hannover.de
Contact: Prof. Schmidt, MD 0049-511-532-0 ext 3000 studienzentrum@mh-hannover.de

Locations
Layout table for location information
Germany
Hannover Medical School Recruiting
Hannover, Lower Saxony, Germany, 30625
Contact: Hannover Medical School    0049-511-532-0 ext 3000    studienzentrum@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
Investigators
Layout table for investigator information
Principal Investigator: Dr. Goedecke, MD Hannover Medical School, Department of Nephrology and Hypertension
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT05954325    
Other Study ID Numbers: EXTINCT post COVID
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannover Medical School:
Post COVID syndrome
Fatigue
Immunoadsorption
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Post-Acute COVID-19 Syndrome
Syndrome
Fatigue
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes