NOT_YET_RECRUITING
Sauna for Long Covid
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.
Conditions:
🦠 Long COVID
🗓️ Study Start (Actual) 1 May 2024
🗓️ Primary Completion (Estimated) 30 May 2025
✅ Study Completion (Estimated) 1 December 2025
👥 Enrollment (Estimated) 21
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
    • 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 reasons other than PASC
    • 2. Known hypersensitivity to infrared heat exposure
    • 3. Breastfeeding, pregnancy or planned pregnancy during study
    • 4. Active suicidal intent ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale44)
    • 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)45
    • 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. Using medication that might impact thermoregulatory capacity within 3 days of receiving WBH treatment (e.g., diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose ASA for prophylactic purposes), non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, selective serotonin reuptake inhibitors \[due to potential interference with effect of WBH36\], or cytokine antagonists)
    • 10. Breast Implants
    • 11. Claustrophobia that would interfere with ability to remain in sauna
    • 12. Fever (Temp \> 99 degrees Fahrenheit) of unknown origin at the time of screening
    • 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. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 June 2023
  • First Submitted that Met QC Criteria 30 June 2023
  • First Posted 5 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 March 2024
  • Last Update Posted 19 March 2024
  • Last Verified March 2024