Clinical trial NCT06204458: Mild Water-filtered Infrared-A Whole-body Hyperthermia in Patients With Post-COVID Syndrome (HyPoCo)
Official title: Evaluation of the Efficacy of Mild Water-filtered Infrared-A Whole-body Hyperthermia to Improve Symptoms and Quality of Life in Patients With Post-COVID Syndrome (HyPoCo)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-COVID Syndrome
Keywords: hyperthermia
fatigue
post-COVID syndrome
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Bavarian State Ministry of Health and Care
First posted: 2024-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the efficacy of mild water-filtered whole-body hyperthermia during outpatient treatment in patients with post-COVID syndrome. The aim is to evaluate whether there can be an improvement in fatigue and quality of life. The duration of the study extends over a treatment period of approximately 2 weeks with two treatment units per week and a follow-up period of 3 months after the outpatient treatment.

Detailed description: A total of about 60 participants over 18 years of age are sought, who will be divided into two groups of equal size after inclusion in the study. All participants will receive the same amount of water-filtered whole-body hyperthermia (WBH) under application of 10 L/min oxygen within the outpatient setting. One group receives the gentle form of WBH, the other group receives the classic, mild WBH, which differ in the intensity of the radiation. Gentle hyperthermia serves as a control group for mild hyperthermia.

All abnormalities are documented by the responsible therapists, doctors and nurses.

Blood parameters are collected before the start, after 2 applications and after the last application during the clinical stay. The aim here is to determine the differential blood count and inflammatory and immune parameters; among other things, autoantibody production is to be examined and monitored during the course of the study. In order to check the possible effectiveness of the treatment, various questionnaire values are also collected. The survey will take place at 3 points in time (at the beginning, after completion of the 4 treatments and 3 months afterwards).

In addition, a diary will be filled out in which patients will provide information on their sleep, personal energy level and pain level as well as their daily step count in order to create an activity profile. All patients receive a paper diary and a pedometer adapted to their individual characteristics in advance. The diary is to be kept from week 0 to week 15.

After completion of the study, qualitative interviews lasting around 30-45 minutes will be conducted with 16-20 participants in weeks 8-10 of the follow-up period. Participants are selected on the basis of socio-demographic and clinical characteristics with the aim of obtaining a sample that is as heterogeneous as possible. The interviews are conducted by telephone.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 75 years
* Confirmed diagnosis of post-COVID syndrome
* Fatigue: at least 51.5 points on the MFI-20 scale.
* Signed declaration of consent

Exclusion Criteria:

* Participation in other clinical studies
* Contraindications for hyperthermia (severe cardiovascular diseases with/above NYHA II, active tumor diseases, acute infections, hyperthyroidism (not adjusted), pregnant and breastfeeding women, epilepsy, high-grade cardiac arrhythmia including atrial fibrillation, multiple sclerosis, major skin lesions, photosensitivity disease, acute exacerbated bronchial asthma/COPD \[Gold II to IV\])
* Pleuritic chest pain
* Hyperthyroidism
* Poorly controlled diabetes mellitus
* Condition after critical illness due to COVID-19
* Patients with active tumor disease, with pneumological, rheumatic, endocrine or neurological concomitant diseases (including dementia, epilepsy, multiple sclerosis), in particular neurological diseases associated with cognitive or sensory disorders
* Severe liver or kidney diseases (liver cirrhosis, post liver transplant, autoimmune hepatitis, dialysis patients, post kidney transplant, acute kidney failure, autoimmune nephropathy)
* Patients with chronic cannabis use (exception: CBD for myalgia), long-term use of WHO class III opioids (e.g. for myalgia/joint pain), long-term use of immunosuppressive medication (steroids, biologics, MTX, leflunomide, azathioprine)
* Patients with psychiatric disorders (bipolar disorder, psychosis, schizophrenia, personality disorder)

Primary outcomes:
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 0
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 3
Secondary outcomes:
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 15
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 0
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 3
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 15
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 0
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 3
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 15
measure: Generic quality of life
timeFrame: Week 0
measure: Generic quality of life
timeFrame: Week 3
measure: Generic quality of life
timeFrame: Week 15
measure: Quality of life (EQ-5D)
timeFrame: Week 0
measure: Quality of life (EQ-5D)
timeFrame: Week 3
measure: Quality of life (EQ-5D)
timeFrame: Week 15
measure: Anxiety and Depression
timeFrame: Week 0
measure: Anxiety and Depression
timeFrame: Week 3
measure: Anxiety and Depression
timeFrame: Week 15
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 0
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 3
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 15
measure: Perceived Stress (PSS-10)
timeFrame: Week 0
measure: Perceived Stress (PSS-10)
timeFrame: Week 3
measure: Perceived Stress (PSS-10)
timeFrame: Week 15
measure: Canadian consensus criteria (CCC)
timeFrame: Week 0
measure: Patient Interview
timeFrame: Week 8-10
measure: Adverse events (AE)
timeFrame: Week 1-2
measure: Patient Diary
timeFrame: Week 1-15
measure: Pedometer (step count)
timeFrame: Week 1-15
Other outcomes:
measure: Blood count
timeFrame: Week 0
measure: Blood count
timeFrame: Week 2
measure: Blood count
timeFrame: Week 3
measure: C-reactive Protein (CRP)
timeFrame: Week 0
measure: C-reactive Protein (CRP)
timeFrame: Week 2
measure: C-reactive Protein (CRP)
timeFrame: Week 3
measure: Blood cell sedimenation rate (BSG)
timeFrame: Week 0
measure: Blood cell sedimenation rate (BSG)
timeFrame: Week 2
measure: Blood cell sedimenation rate (BSG)
timeFrame: Week 3
measure: Cytokine panel
timeFrame: Week 0 - baseline status
measure: Cytokine panel
timeFrame: Week 2 - before 3rd application of hyperthermia
measure: Cytokine panel
timeFrame: Week 3 - after last application of hyperthermia
measure: post-Covid autoantibodies
timeFrame: Week 0 - baseline status
measure: post-Covid autoantibodies
timeFrame: Week 2 - acute effects
measure: post-Covid autoantibodies
timeFrame: Week 3 - acute effects
measure: Post-Covid pathogen reactivation
timeFrame: Week 0 - baseline status
measure: Post-Covid pathogen reactivation
timeFrame: Week 3 - acute effects
measure: Real time deformability cytometry (RT-DC)
timeFrame: Week 0 - baseline status
measure: Real time deformability cytometry (RT-DC)
timeFrame: Week 3 - acute effects
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg
Study officials:
affiliation: Sozialstiftung Bamberg
name: Jost Langhorst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: