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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 18-65 years of age

• English language proficiency

• Ability to provide informed consent

• Ability to lie supine (on back) for 2 hours (required for sauna sessions)

• 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)

• 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)

• Individuals of childbearing potential must use an acceptable form of birth control.

Locations
United States
Massachusetts
Depression Clinical and Research Program
RECRUITING
Boston
Contact Information
Primary
Maren Nyer, PhD
mnyer@mgh.harvard.edu
6072796290
Backup
David Mischoulon, MD, PhD
dmischoulon@mgh.harvard.edu
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 21
Treatments
Experimental: verum whole body hyperthermia
WBH will be completed with a Clearlight Sauna Dome and ancillary equipment to monitor core body temperature. For the verum WBH, participants will be brought to a core body temperature of 101.3°F.
Sham_comparator: sham whole body hyperthermia
The sham condition will be identical to the active WBH condition. Time and other procedures will be consistent. Mild heat will be used to mimic an active WBH session.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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