Trial · NCT05668091
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.1 Physical Health Summary Score | Day 28 | The difference in NIH PROMIS-29 version 2.1 Physical Health Summary Score at Day 28 between nirmatrelvir/ritonavir and placebo/ritonavir treatment estimated with a longitudinal analysis of covariance (ANCOVA) that controls for age, sex, and baseline PROMIS-29 Physical Health Summary Score. PROMIS-29 was selected as a well-validated, non-proprietary general health assessment. PROMIS-29 is a self-report 29-item questionnaire from 7 primary PROMIS domains (depression, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with participation in social roles). PROMIS-29 assessments are transformed into a T-score metric, so that scores have a normal distribution with a population mean T-score of 50 and standard deviation of 10. Higher scores mean better outcomes. |
| Secondary | Modified General Symptom Questionnaire-30 (Modified GSQ-30) | Day 28 and at Day 15, and Weeks 6, 10, 14, 18, and 24 | Difference in GSQ-30 between nirmatrelvir/ritonavir and placebo/ritonavir groups. The GSQ-30 is a 30-item questionnaire developed to assess symptom burden over a 2-week time period. The GSQ-30 asks: "how much have you been bothered by any of the following?" with 5 options: "not at all," "a little bit," "somewhat," "quite a bit," and "very much" (scored 0-4); total score ranges from 0 to 120. The GSQ-30 reflects physical and neuropsychiatric symptoms. An additional question (not included in the scoring) asks whether any of the 30 GSQ symptoms have impaired work, social, or family functioning, and asks the rank order of severity (up to 7 items) to identify the symptoms of most concern to the individual. Total score ranges from 0 to 120; a higher score means worse outcome. To align with the other trial questionnaires, we will modified the recall period to 1-week. |
| Secondary | PROMIS® Cognitive Function v.2.0 - Short Form 6a | Day 28 and at Day 15, and Weeks 6, 10, 14, 18 and 24 | Difference in PROMIS® Cognitive Function v.2.0 - Short Form 6a between nirmatrelvir/ritonavir and placebo/ritonavir groups. The PROMIS® Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS® Cognitive Function item bank that assesses patient-perceived cognitive deficits. |
| Secondary | COVID Core Outcome Measure for Recovery | Day 28 and at Day 15, and Weeks 14 and 24 | Difference in COVID Core Outcome Measure for Recovery Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The COVID Core Outcome Measure for Recovery is a single item intended to measure a return to the pre-illness state. Its purpose in this trial is to have a question that directly assesses the participant's perception of their recovery from their SARS-CoV-2 infection. It is scored on a 5-point Likert scale from 0 (completely recovered) to 4 (not recovered at all). Complete recovery means the participant no longer has symptoms related to illness and can do usual daily activities and has returned to their previous state of health and mind (before illness). |
| Secondary | EuroQol EQ-5D-5L Utility Score-VAS (USA Version) | Day 28 and at Day 15, and Weeks 14 and 24 | Difference in EuroQol EQ-5D-5L Utility Score and VAS Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The EQ-5D-5L is a descriptive system in which respondents are asked to report their current state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which has 5 levels of response (no problems, slight problems, moderate problems, severe problems, and extreme problems). There is also a visual analogue scale (VAS). In total there are 6 items. The higher the EQ-VAS score, the better the quality of life. |
| Secondary | Functional Assessment of Chronic Illness Therapy (FACIT)-Item GP5 | Day 28 and Day 15 | Difference in FACIT-Item GP5 Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The single-item FACIT-Item GP5, "I am bothered by side effects of treatment," was included to have a question on the experience with the trial drug and will be prefaced to focus on the trial drug. It is a summary measure of the overall tolerability of treatment, with 5 levels of response: not at all, a little bit, somewhat, quite a bit, and very much. It has a 7-day recall period. |
| Secondary | PROMIS-29 Overall and Mental Health Summary Score | Day 28 and at Day 15, and Weeks 6, 10, 14, 18 and 24 | Difference in PROMIS-29 Overall and Mental Health Summary Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and 7 health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using 4 items per domain. There is no total score, but each axis forms its own score. Higher scores mean better outcomes. |
| Secondary | Difference in number of hospitalizations and deaths | Day 1 through Week 24 (End of Study) | Difference in occurrence of hospitalizations and deaths between nirmatrelvir/ritonavir and placebo/ritonavir groups. |
| Secondary | Proportion of participants who experience individual Serious Adverse Events (SAE) | up to 6 weeks post starting study drug | Proportion of participants who experience individual SAEs |
| Secondary | Incidence of SAEs leading to discontinuation | Day 15 | The number of SAEs leading to discontinuation in the study |
| Secondary | Patient Global Impression of Severity | Baseline, Day 15, Day 28, Week 6, Week 10, Week 14, Week 24 | Based on FDA's recommendations, we will include the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales. These anchor scales can help interpret a clinically meaningful within-patient score change for the key primary and secondary endpoints. We will include two PGIS and two PGIC scales. The PGIS 1 is a single-item questionnaire that asks respondents: "Overall, how would you rate the severity of your long COVID symptoms over the past week?". Responses are: "none," "mild," "moderate," "severe," and "very severe." The PGIS 2 asks "Overall, how would you rate the impact of your symptoms on your overall health over the past week?". Responses are: "none," "mild," "moderate," "severe," and "very severe." The PGISs will be administered at the same intervals as the primary endpoint (PROMIS-29). |
| Secondary | Patient Global Impression of Change | Day 15, Day 28, Week 6, Week 10, Week 14, Week 24 | The PGIC 1 asks: "Overall, how would you rate the change in your long COVID symptoms since you started the study?". There 7-point scale options: 1) "very much better", 2) "much better", 3) "minimally better", 4) "no change", 5) "minimally worse", 6) "much worse", or 7) "very much worse". Higher scores indicate a change for the worse. The PGIC 2 asks "Overall, how would you rate your overall health since you started the study?". There 7-point scale options: 1) "very much better", 2) "much better", 3) "minimally better", 4) "no change", 5) "minimally worse", 6) "much worse", or 7) "very much worse". Higher scores indicate a change for the worse. The PGICs will be administered at the same intervals as the primary endpoint (PROMIS-29) with the exception of baseline. These instruments have been used extensively in patient-centered research. |
| Other | Exploratory Outcome Measure | Baseline, Day 14 and at Day 28 | Differences in immune signatures between baseline and nirmatrelvir/ritonavir treatment relative to placebo/ritonavir. Immunophenotyping assays will include flow cytometry, multiplex proteomic analysis, linear peptide profiling, and rapid extracellular antigen profiling, among others. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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