Post-COVID SyndromeHyPoCoNCT06204458
Mild Water-filtered Infrared-A Whole-body Hyperthermia in Patients With Post-COVID Syndrome (HyPoCo)
A study testing mild hyperthermia group in people with Post-COVID Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-COVID Syndrome
- What is being tested?
- mild hyperthermia group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2024to 31 May 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Post-COVID Syndrome
- Being tested
- mild hyperthermia group, sham group
- Keywords
- hyperthermia, fatigue, post-COVID syndrome
- Medical subject headings
- Hyperthermia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild hyperthermia groupOther
The hyperthermia treatment is carried out in a cycle of two treatments per week, with at least one day in between, over a period of two weeks, according to the manufacturer's instructions. For better tolerability, the application takes place under administration of 10L/min oxygen. According to the guidelines, the rectal (possibly vaginal) temperature (as body core temperature), heart rate and oxygen saturation (Sp02) are continuously determined during the hyperthermia treatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call.
sham groupOther
Within the application, patients in the Sham group will undergo a hyperthermia application with virtually no overheating. To achieve this, the patients are positioned on the hyperthermia device in the same way as the intervention group. An insulating foil applied beforehand prevents direct irradiation with water-filtered infrared-A radiation. This prevents an increase in temperature. Due to the insulating blanket and the natural heat from the device and body, patients in the Sham group experience a gentle warmth that cannot be compared with regular whole-body hyperthermia and an increase in core body temperature of around 1.5°C. The number of treatments, the lighting conditions and procedures including 10L/min oxygen supply, is equal to the treatments in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| mild hyperthermia group | Experimental | For the study, the method of passive whole-body hyperthermia is used. The IRATHERM®1000 system (Von Ardenne Institute for Applied Medical Research/Dresden) is used, in which the entire body is heated to a core body temperature above the physiological 37°C under the application of 10L/min oxygen. The aim is to achieve a core body temperature of 38.5°C within the framework of mild whole-body hyperthermia. After this warm-up phase, a temperature plateau phase of about 60 minutes follows, in which an attempt is made to maintain the core body temperature of 38.5°C. In the temperature plateau phase, a slight increase in the body core temperature is usually observed. The total time required for a session is given as 1.5 to 2 hours, but this depends on the individual constitution and daily condition of the patient and can be subject to fluctuations. Receives: Other: mild hyperthermia group |
| sham group | Sham comparator | Within the patient information, privacy policy, etc., there is talk of "gentle hyperthermia" and classic, "mild hyperthermia". This serves to introduce the sham intervention as a control group compared to the patient. Lighting conditions, procedures, instructions and explanations are indistinguishable. Within the application, patients of the sham group will receive a hyperthermia application almost without overheating. In order to achieve this, the patients will be positioned on the IRATHERM®1000 in accordance with the Von Ardenne Institute's regulations. Due to the insulating blanket and the natural device and body heat, the patients of the sham group experience a gentle warmth, which is not the same as regular whole-body hyperthermia and an increase in the body core temperature of about 1.5 °C. In the sham setting, the core body temperature increases by about 0.3 to 0.4 °C within a 55-minute session. Receives: Other: sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensionl Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).
Measured: Week 0
Multidimensionl Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).
Measured: Week 3
Secondary outcomes (27)
Multidimensionl Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).
Measured: Week 15
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments.
Measured: Week 0
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments.
Measured: Week 3
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments.
Measured: Week 15
Pittsburgh Sleep quality index (PSQI)
An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from ("Not during the past month" to "thee or more times a week"). The questions can be calculated in seven subscales.
Measured: Week 0
Pittsburgh Sleep quality index (PSQI)
An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from ("Not during the past month" to "thee or more times a week"). The questions can be calculated in seven subscales.
Measured: Week 3
Pittsburgh Sleep quality index (PSQI)
An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from ("Not during the past month" to "thee or more times a week"). The questions can be calculated in seven subscales.
Measured: Week 15
Generic quality of life
Short Form SF-12 Health Survey Questionnaire; A low total value correlates with a poor quality of life, a higher one with a better one.
Measured: Week 0
Generic quality of life
Short Form SF-12 Health Survey Questionnaire; A low total value correlates with a poor quality of life, a higher one with a better one.
Measured: Week 3
Generic quality of life
Short Form SF-12 Health Survey Questionnaire; A low total value correlates with a poor quality of life, a higher one with a better one.
Measured: Week 15
Quality of life (EQ-5D)
The EQ-5D measures 5 dimensions of quality of life (mobility, self-care, general activities, pain/physical discomfort and anxiety/depression) as well as the general state of health on a VAS from 0-100.
Measured: Week 0
Quality of life (EQ-5D)
The EQ-5D measures 5 dimensions of quality of life (mobility, self-care, general activities, pain/physical discomfort and anxiety/depression) as well as the general state of health on a VAS from 0-100.
Measured: Week 3
Quality of life (EQ-5D)
The EQ-5D measures 5 dimensions of quality of life (mobility, self-care, general activities, pain/physical discomfort and anxiety/depression) as well as the general state of health on a VAS from 0-100.
Measured: Week 15
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.
Measured: Week 0
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.
Measured: Week 3
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.
Measured: Week 15
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Measured: Week 0
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Measured: Week 3
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Measured: Week 15
Perceived Stress (PSS-10)
Perceived stress is determined using the Perceived Stress Scale (PSS). The PSS is an international standard instrument for recording subjective stress levels. The official German 10-item version is used in the study.
Measured: Week 0
Perceived Stress (PSS-10)
Perceived stress is determined using the Perceived Stress Scale (PSS). The PSS is an international standard instrument for recording subjective stress levels. The official German 10-item version is used in the study.
Measured: Week 3
Perceived Stress (PSS-10)
Perceived stress is determined using the Perceived Stress Scale (PSS). The PSS is an international standard instrument for recording subjective stress levels. The official German 10-item version is used in the study.
Measured: Week 15
Canadian consensus criteria (CCC)
This is a questionnaire for the diagnosis of CFS/ME (Carruthers et al. 2003). This definition scheme can be used to clinically confirm the diagnosis of CFS/ME. The list of criteria includes the following symptom complexes: Fatigue, exercise intolerance (PEM), sleep disturbances, pain, neurological or cognitive symptoms, autonomic symptoms, neuroendocrine symptoms and immunological symptoms.
Measured: Week 0
Patient Interview
Qualitative telephone interviews with 16-20 patients of the mild whole-body hyperthermia group (Experimental group) to get detailed experiences of the patients (30-45 min).
Measured: Week 8-10
Adverse events (AE)
Description of adverse events during the interventions by therapists.
Measured: Week 1-2
Patient Diary
Documentation of pain progression, energy level, sleep, medication intake, number of steps, adverse events
Measured: Week 1-15
Pedometer (step count)
Individual activity profile
Measured: Week 1-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start20 Feb 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID SyndromeStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian State Ministry of Health and Care
- Responsible party
- Principal investigator, Jost Langhorst, Universität Duisburg-Essen
- Investigators
- Jost Langhorst, Prof. Dr., Principal investigator, Sozialstiftung Bamberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204458
- Sponsor's protocol ID
- 23050
- Acronym
- HyPoCo
- Status last verified
- Oct 2024
- First submitted
- 11 Jan 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06204458
- Acronym / sponsor ID
- HyPoCo / 23050
- Conditions
- Post-COVID Syndrome
- Keywords
- hyperthermia, fatigue, post-COVID syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Bavarian State Ministry of Health and Care
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 12 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild hyperthermia group | Experimental | Other: mild hyperthermia groupFor the study, the method of passive whole-body hyperthermia is used. The IRATHERM®1000 system (Von Ardenne Institute for Applied Medical Research/Dresden) is used, in which the entire body is heated to a core body temperature above the physiological 37°C under the application of 10L/min oxygen. The aim is to achieve a core body temperature of 38.5°C within the framework of mild whole-body hyperthermia. After this warm-up phase, a temperature plateau phase of about 60 minutes follows, in which an attempt is made to maintain the core body temperature of 38.5°C. In the temperature plateau phase, a slight increase in the body core temperature is usually observed. The total time required for a session is given as 1.5 to 2 hours, but this depends on the individual constitution and daily condition of the patient and can be subject to fluctuations. |
| sham group | Sham comparator | Other: sham groupWithin the patient information, privacy policy, etc., there is talk of "gentle hyperthermia" and classic, "mild hyperthermia". This serves to introduce the sham intervention as a control group compared to the patient. Lighting conditions, procedures, instructions and explanations are indistinguishable. Within the application, patients of the sham group will receive a hyperthermia application almost without overheating. In order to achieve this, the patients will be positioned on the IRATHERM®1000 in accordance with the Von Ardenne Institute's regulations. Due to the insulating blanket and the natural device and body heat, the patients of the sham group experience a gentle warmth, which is not the same as regular whole-body hyperthermia and an increase in the body core temperature of about 1.5 °C. In the sham setting, the core body temperature increases by about 0.3 to 0.4 °C within a 55-minute session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| mild hyperthermia groupThe hyperthermia treatment is carried out in a cycle of two treatments per week, with at least one day in between, over a period of two weeks, according to the manufacturer's instructions. For better tolerability, the application takes place under administration of 10L/min oxygen. According to the guidelines, the rectal (possibly vaginal) temperature (as body core temperature), heart rate and oxygen saturation (Sp02) are continuously determined during the hyperthermia treatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call. | Other | mild hyperthermia group |
| sham groupWithin the application, patients in the Sham group will undergo a hyperthermia application with virtually no overheating. To achieve this, the patients are positioned on the hyperthermia device in the same way as the intervention group. An insulating foil applied beforehand prevents direct irradiation with water-filtered infrared-A radiation. This prevents an increase in temperature. Due to the insulating blanket and the natural heat from the device and body, patients in the Sham group experience a gentle warmth that cannot be compared with regular whole-body hyperthermia and an increase in core body temperature of around 1.5°C. The number of treatments, the lighting conditions and procedures including 10L/min oxygen supply, is equal to the treatments in the intervention group. | Other | sham group |
Primary outcome
Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 0
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).
Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 3
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).
27 secondary outcomes
Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 15
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Time frame: Week 0
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Time frame: Week 3
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Time frame: Week 15
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 0
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 3
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 15
Generic quality of life
Time frame: Week 0
Generic quality of life
Time frame: Week 3
Generic quality of life
Time frame: Week 15
Quality of life (EQ-5D)
Time frame: Week 0
Quality of life (EQ-5D)
Time frame: Week 3
Quality of life (EQ-5D)
Time frame: Week 15
Anxiety and Depression
Time frame: Week 0
Anxiety and Depression
Time frame: Week 3
Anxiety and Depression
Time frame: Week 15
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 0
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 3
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 15
Perceived Stress (PSS-10)
Time frame: Week 0
Perceived Stress (PSS-10)
Time frame: Week 3
Perceived Stress (PSS-10)
Time frame: Week 15
Canadian consensus criteria (CCC)
Time frame: Week 0
Patient Interview
Time frame: Week 8-10
Adverse events (AE)
Time frame: Week 1-2
Patient Diary
Time frame: Week 1-15
Pedometer (step count)
Time frame: Week 1-15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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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.
Jost Langhorst, Prof. Dr. principal investigator
Sozialstiftung Bamberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mild hyperthermia group in people with Post-COVID Syndrome, run by Universität Duisburg-Essen 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Apr 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?
Results are not available in the source record.
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?
Multidimensionl Fatigue Inventory (MFI-20) (time frame: Week 0). The study lists 2 primary outcomes in all. 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 11 Apr 2025.