Long COVID
Conditions
Brief summary
Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The investigators aim to study the feasibility and treatment effect of this procedure for patients experiencing Long Covid symptoms.
Detailed description
This proposed trial will examine, for the first-time, study whole-body hyperthermia (WBH) as a treatment for PASC. The investigators will enroll 21 people with PASC who will be randomized into two conditions with different temperature WBH. The primary aims will explore acceptability and feasibility, reduction of fatigue (primary symptom), and potential mechanisms (inflammation and sleep). Inflammation and sleep have both been shown to be dysregulated in PASC and addressed by WBH in other populations. The investigators will use week 2 as the primary endpoint. However, patients will be followed for 4 and 6 weeks to monitor the duration of effect.
Interventions
DEVICEwhole body hyperthermia
heat will be applied to the participant through a sauna to increase core body temperature
Sponsors
University of California, San Francisco
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Subjects will be randomized to one of two WBH groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years of age 2. English language proficiency 3. Ability to provide informed consent 4. Ability to lie supine (on back) for 2 hours (required for sauna sessions) 5. Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening (Note: clinician judgment can override lack of positive COVID test with clear Long Covid onset and presentation) 6. The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF43) raw score of 21 or greater at Screening (onset of fatigue confirmed post-infection as in other studies of PASC) 7. Individuals of childbearing potential must use an acceptable form of birth control.
Exclusion criteria
1. Fatigue for known reasons other than PASC (e.g. longstanding diagnosis of Chronic Fatigue Syndrome pre-dating Long Covid, low thyroid, multiple sclerosis, AIDS related fatigue, mononucleosis), as determined by clinical discretion of study investigators 2. Known hypersensitivity to infrared heat exposure, significant history of heat stroke 3. Breastfeeding, pregnancy or planned pregnancy during study 4. Active suicidal intent 5. History of bipolar disorder, psychotic disorders, eating disorders, obsessive compulsive disorder, and/or substance use or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)44 6. Positive urine toxicology screen for illicit drug use 7. Any serious unstable medical condition 8. Inability to fit into the sauna device. Morbid obesity (BMI \> 40) and/or body shape that might increase the risk of cutaneous burning from the device (because of skin being too close to the heat). 9. Back pain that would interfere with ability to lay on hard surface 10. Using medication that might impact thermoregulatory capacity and cannot be held for an appropriate length (at least one half-life) as determined by clinician judgment prior to receiving WBH treatment 11. Breast Implants 12. Claustrophobia that would interfere with ability to remain in sauna 13. Unsafe cardiac status as defined by abnormal ECG reading at screening visit or as determined by study doctor or subject's physician 14. History of or current diagnosis of thrombosis or thrombophilia 15. History of hemophilia 16. History of febrile seizures or seizure disorders 17. Any new treatments/medications for long-COVID that have started in the past 3 months 18. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF) | 2-weeks (primary endpoint) follow up at 6 weeks | provides a more in depth assessment of fatigue as compared to the PROMIS 29 and consists of 7 items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Uses a range of 7-35, higher scores indicate higher fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ) | 2-weeks (primary endpoint) follow up at 6 weeks | a well-established, brief self-administered 9-item depression screening and monitoring tool. Uses a range of 0-27 with higher scores indicating greater depressive symptoms. |
| The Perceived Stress Scale (PSS) | 2-weeks (primary endpoint) follow up at 6 weeks | consists of 10 items and measures the frequency with which perceived stressful life situations are experienced. Scores can range from 0 to 40 with higher scores indicating higher perceived stress. |
| Patient-Reported Outcomes Measurement Information System Cognitive Abilities | 2-weeks (primary endpoint) follow up at 6 weeks | items target positive self-assessments of cognitive functioning with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate better perceived cognitive functioning. |
| Patient-Reported Outcomes Measurement Information System Cognitive Concerns | 2-weeks (primary endpoint) follow up at 6 weeks | items are worded negatively and express concerns in the same areas as in the Patient-Reported Outcomes Measurement Information System Cognitive Abilities with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate greater cognitive concerns. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | 2-weeks (primary endpoint) follow up at 6 weeks | assesses seven health domains (i.e., physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. There is no total score, and scores range from 4-10 for each health domain (with 4 items for each of the 7 health domains). Scores are transformed into t scores with higher scores indicating better health. |
| The Composite Autonomic Symptom Score (COMPASS-31) | 2-weeks (primary endpoint) follow up at 6 weeks | consists of 31 items and measures autonomic and neurodegenerative system symptoms. Total scores range from 0 to 100 with greater scores indicating greater autonomic dysfunction. |
| The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) | 2-weeks (primary endpoint) follow up at 6 weeks | 13-item questionnaire designed to assess the severity of fatigue and its impact on daily functioning and quality of life. Respondents rate items on a 5-point scale, with higher scores indicating less fatigue. Total scores can range between 0 and 52. |
| Long-COVID Symptom Tool (Long-COVID ST) | 2-weeks (primary endpoint) follow up at 6 weeks | assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. Scores can range from 0 to 53 with higher scores indicating greater severity of symptoms. |
| Long-COVID Impact Tool (Long-COVID IT) | 2-weeks (primary endpoint) follow up at 6 weeks | assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. The scale also measures the impact from these symptoms. Scores can range from 0 to 60 with higher scores indicating greater life impact. |
| Positive and Negative Affective Schedule (PANAS) | 2-weeks (primary endpoint) follow up at 6 weeks | consists of two 10-item mood scales to measure positive and negative affect. Raw scores range from 10 to 50. Higher scores indicate more of a positive affect. |
Countries
United States
Contacts
Primary ContactMaren Nyer, PhD
Backup ContactDavid Mischoulon, MD, PhD
Outcome results
None listed