Research suggests that Whole Body Hyperthermia in a sauna-like environment can reducesymptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. Theinvestigators aim to study the feasibility and treatment effect of this procedure forpatients experiencing Long Covid symptoms.
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.
Device: whole body hyperthermia
heat will be applied to the participant through a sauna to increase core body temperature
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.
Depression Clinical and Research Program
Boston, Massachusetts, United States
Investigator: Maren Nyer, PhD
Contact: 617-643-4897
mnyer@partners.org
Maren Nyer, PhD
6072796290
mnyer@mgh.harvard.edu
David Mischoulon, MD, PhD
dmischoulon@mgh.harvard.edu
Not Provided