NCT07128082进行中（未招募）2 期
The Long COVID Treatment Trial
Scripps Translational Science Institute1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年10月30日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)
研究概览
简要总结
The goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control trial will allow us to measure the effect of the treatment by having half of the participants take the medication and half take a placebo that has no medication. Participants will take the medication (or placebo) they are given and complete study surveys for 12 months. All of the study tasks are done remotely from the comfort of a participants home.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older Living in the United States Able to read and understand English or Spanish Willing and able to participate in study interventions and activities, including;
- •Access to an internet connected device
- •Informed Consent
- •Medication schedule
- •Adverse Event reporting
- •Weight reporting
- •Use of wearable activity tracker
- •Completing at home blood collections, if selected Meets the NASEM definition of Long COVID: an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems
- •Ability to verify identity Ability to verify diagnosis Agree to notify the study team if you start any other Long COVID treatments while enrolled in the study.
- •Complete the Fatigue Severity Scale with a minimum score of 36
排除标准
- •Certain vulnerable populations (prisoners, children, fetuses, and institutionalized individuals)
- •Women who are pregnant, excluded due to unknown risks to a fetus
- •Personal or family history of medullary thyroid carcinoma
- •History of severe gastrointestinal disease
- •Diagnosis of gastroparesis
- •Worsening or chronic renal failure
- •History of pancreatitis
- •Multiple Endocrine Neoplasia syndrome type 2
- •Known serious hypersensitivity to tirzepatide
- •Already taking tirzepatide or another GLP-1 agonist
- •Medication contraindications to tirzepatide
- •History of suicidal attempts and/or active suicidal ideation
- •Underweight (BMI under 18.5)
- •Planning to undergo elective surgery or procedures requiring general anesthesia or deep sedation in the next 12 months
- •Symptoms of fatigue and/or brain fog that predated infection with COVID-19
研究组 & 干预措施
500 Participants will be randomized to receive placebo instead of active study medication.
Placebo Comparator
干预措施: Placebo (Drug)
500 Participants will be randomized to receive active study medication.
Active Comparator
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)
时间窗: 12 months
The average difference in Fatigue Severity Scale (minimum score 9, maximum score 63, with higher scores indicating worse fatigue) between treatment and control groups of adults with Long COVID at month 3 or month 12 after study start
次要结局
- Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores(12 months)
- Secondary Outcome: Presence of and changes in post-exertional malaise, a condition that occurs in subsets of Long COVID and IACIs, measured by DePaul Symptom Questionnaire Post Exertional Malaise (DSQ-PEM)(12 month)
- Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey(12 months)
研究者
研究点 (1)
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