Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
- Conditions
- Long COVIDPost Acute Sequelae of COVID-19Post-Acute COVID-19
- Interventions
- Other: Placebo
- Registration Number
- NCT06161688
- Lead Sponsor
- Timothy Henrich
- Brief Summary
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population.
- Detailed Description
The study will enroll approximately 40 participants who meet the World Health Organization (WHO) Long COVID criteria. Participants will be enrolled at a single center and randomized 1:1 to receive ensitrelvir fumaric acid (Ensitrelvir: S-217622), given orally for 5 days, or placebo. Subjects randomized to receive Ensitrelvir will take 375 mg on day 1, followed by 125 mg daily for 4 additional days. Evaluations will take place at baseline and at timepoints up to 60 days post-initiation of study drug.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ensitrelvir (S-217622) Ensitrelvir Ensitrelvir fumaric acid (S-217622) given orally 375 mg on day 1 followed by 125 mg daily for 4 additional days Placebo Placebo Placebo administered orally for 5 days
- Primary Outcome Measures
Name Time Method Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline. Baseline and Day 10 This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the PROMIS-29 scale between baseline and day 10. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The primary outcome evaluated will be change in the Physical Health Summary Score.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life Score (5-Item EuroQol EQ-5D-5L) Index Value Score from Baseline. Baseline and Day 10 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week.
Change in 6 Minute Walking Test (6MWT) from Baseline Baseline and Day 10 This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on 6MWT performance between baseline and at 10 days following administration. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.
Change in Everyday Cognition Form instrument from Baseline Baseline and Day 10 The ECog is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID. This version of the ECog questionnaire uses 41 questions to assess these domains.
Change in Neurocognition Index (NCI) score from the CNS-VS from Baseline Baseline and Day 10 A neurocognitive assessment to assess motor, emotional, sensory, and cognitive function. It is available in English and Spanish and is administered using an iPad or computer.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline. Baseline and Day 30 This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the PROMIS-29 scale between baseline and 30 days following administration. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). We will evaluate the change in the Physical Health Summary Score at these timepoints.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score from Baseline. Baseline and Day 30 This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the PROMIS-29 scale between baseline and day 30 following administration. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). We will evaluate the change in the Mental Health Summary Score at this timepoint.
Change in Quality of Life (Global Health Score) on a 100-point Visual-Analogue Scale from Baseline Baseline and Day 10 This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on self-reported score on a 100-point visual-analogue scale, where 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.
Change in Duke Activity Status Index (DASI) from Baseline Baseline and Day 10 The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities.
Change in Orthostatic Intolerance Score from Baseline Baseline and Day 10 This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the OHQ scale between baseline and 10 days following administration. The scale assesses symptoms and their impact.
Change in World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) questionnaire from Baseline Baseline and Day 10 The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.
Patient Global Impression of Change (PGIC) at D10 Day 10 The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. We will use a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health.
Change in Active Stand Test from Baseline Baseline and Day 10 Measurements of heart rate and blood pressure measured after resting lying down, and at standardized increments for up to 10 minutes (as tolerated).
Trial Locations
- Locations (1)
UCSF/Zuckerberg San Francisco General Hospital
🇺🇸San Francisco, California, United States