Trial · NCT06161688
Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
NCT06161688, Phase 2, Active not recruiting, Timothy Henrich
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID. Trials, record NCT06161688. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06161688
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
- NCT number
- NCT06161688
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Timothy Henrich
- Conditions
- Long COVID, Post Acute Sequelae of COVID-19, Post-Acute COVID-19
- Interventions
- Ensitrelvir, Placebo
- First posted
- 2023-12-08
- Last updated
- 2026-04-02
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at 10 post-\[ADD\]. 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). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score | Day 30 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 30 post-randomization. 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). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 10 post-randomization. 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). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score | Day 30 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 post-randomization. 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). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health. |
| Secondary | Quality of Life (Global Health Score) on a 100-point Visual-Analogue Scale | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 10 post-randomization. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine. |
| Secondary | Quality of Life Score (5-Item EuroQol EQ-5D-5L) Index Value Score | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 10 post-randomization. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life. |
| Secondary | Duke Activity Status Index (DASI) | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean DASI at Day 10 post-randomization. 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. A higher score indicates higher functional capacity. |
| Secondary | Orthostatic Hypotension Questionnaire (OHQ) Composite Score | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean OHQ composite score at Day 10 post-randomization. The Orthostatic Hypotension Questionnaire (OHQ) was developed as a psychometric tool to capture patients' experience quantifying symptomatic burden and functional limitations caused by neurogenic orthostatic hypotension The OHQ composite score range is 0 -10 with a higher score indicating higher burden. |
| Secondary | World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) Questionnaire | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 10 post-randomization. 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. The range is scored from 0-48, with a higher score indicating a higher level of disability. |
| Secondary | Patient Global Impression of Change (PGIC) | Day 10 | This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 10 post-randomization. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used 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. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06161688
GET https://conductscience.org/api/trials/v1/NCT06161688/registered