Sauna for Long Covid

Long COVID Clinical Trial

Official title:

A Pilot Study of Whole Body Hyperthermia for Long Covid or Post-Acute Sequelae of COVID-19 (PASC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05931497
• Other study ID #: 2023p000852
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Maren Nyer, PhD
• Phone: 6072796290
• Email: mnyer[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 weeks to monitor the duration of effect.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: December 1, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Long COVID

Intervention

Device:
• whole body hyperthermia
heat will be applied to the participant through a sauna to increase core body temperature

Locations

Country	Name	City	State
United States	Depression Clinical and Research Program	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)	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.	6-weeks
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	6-weeks