A Pilot Study of Whole Body Hyperthermia for Long Covid or Post-Acute Sequelae of COVID-19 (PASC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Known hypersensitivity to infrared heat exposure, significant history of heat stroke
- •Breastfeeding, pregnancy or planned pregnancy during study
- •Active suicidal intent
- •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
- •Positive urine toxicology screen for illicit drug use
- •Any serious unstable medical condition
- •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).
- •Back pain that would interfere with ability to lay on hard surface
- •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
- •Breast Implants
- •Claustrophobia that would interfere with ability to remain in sauna
- •Unsafe cardiac status as defined by abnormal ECG reading at screening visit or as determined by study doctor or subject's physician
- •History of or current diagnosis of thrombosis or thrombophilia
- •History of hemophilia
- •History of febrile seizures or seizure disorders
- •Any new treatments/medications for long-COVID that have started in the past 3 months
- •A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity.
结局指标
主要结局
The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)
时间窗: 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.
次要结局
- Patient-Reported Outcomes Measurement Information System Cognitive Concerns(2-weeks (primary endpoint) follow up at 6 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(2-weeks (primary endpoint) follow up at 6 weeks)
- Patient Health Questionnaire-9 (PHQ)(2-weeks (primary endpoint) follow up at 6 weeks)
- Patient-Reported Outcomes Measurement Information System Cognitive Abilities(2-weeks (primary endpoint) follow up at 6 weeks)
- Positive and Negative Affective Schedule (PANAS)(2-weeks (primary endpoint) follow up at 6 weeks)
- The Composite Autonomic Symptom Score (COMPASS-31)(2-weeks (primary endpoint) follow up at 6 weeks)
- Long-COVID Symptom Tool (Long-COVID ST)(2-weeks (primary endpoint) follow up at 6 weeks)
- Long-COVID Impact Tool (Long-COVID IT)(2-weeks (primary endpoint) follow up at 6 weeks)
- The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)(2-weeks (primary endpoint) follow up at 6 weeks)
- The Perceived Stress Scale (PSS)(2-weeks (primary endpoint) follow up at 6 weeks)
研究者
Maren Nyer
Clinical Psychologist
Massachusetts General Hospital