Trial · NCT05823896
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in quality of life over time | Baseline and day 16 | The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale. |
| Secondary | Change from baseline in quality of life over time | Baseline and days 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale. |
| Secondary | Change from baseline in hemodynamic response over time | Baseline and days 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on hemodynamic response (only patients diagnosed with postural orthostatic tachycardia syndrome, POTS). Change from baseline in delta maximum heart rate during active standing test. |
| Secondary | Change from baseline in dysautonomia over time | Baseline and days 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on dysautonomia symptoms. Change from baseline as measured using the Composite Autonomic Symptom Score (Compass31) questionnaire. |
| Secondary | Change from baseline in fever in patients with POTS over time | Baseline and days 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on fever (only patients diagnosed with POTS). Change from baseline in POTS-specific symptoms as measured by using the Malmo POTS score, MAPS. |
| Secondary | Change from baseline in endothelial function over time | Baseline and day 45 | The effect of oral administration of nirmatrelvir/ritonavir on reactive hyperemia index. Change from baseline in endothelial function measured using the EndoPat® device. |
| Secondary | Change from baseline in heart rate over time | Baseline and days 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on 24-h average heart rate. Change from baseline in heart rate using ECG monitoring device. |
| Secondary | Change from baseline in fever over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on fever. Change from baseline in body temperature. |
| Secondary | Change from baseline in physical capacity over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on physical capacity. Change from baseline as measured by 6-minute walk test. |
| Secondary | Change from baseline in handgrip strength over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on handgrip strength. Change from baseline as measured by JAMAR hand dynamometer. |
| Secondary | Change from baseline in physical activity over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on physical activity. Change from baseline as measured by accelerometer. |
| Secondary | Change from baseline in post-exertional malaise over time | Baseline and day 90 | The effect of oral administration of nirmatrelvir/ritonavir on post-exertional malaise. Change from baseline in total score as measured by the Post-Exertional Malaise (PEM) short form. |
| Secondary | Change from baseline in fatigue over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on fatigue. Change from baseline as measured by the fatigue severity scale (FSS) and mental fatigue scale (MFS). |
| Secondary | Change from baseline in cognitive dysfunction over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on cognitive dysfunction. Change from baseline over time as measured by the Montreal Cognitive Assessment (MoCA) test. |
| Secondary | Change from baseline in dyspnea over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on dyspnea measured as change from baseline in respiratory symptoms using the Chronic obstructive disease assessment (CAT) and Modified Medical Research Council (mMRC) tests. |
| Secondary | Change from baseline in plasma biomarkers over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on plasma biomarkers. Change from baseline in the following plasma biomarkers: D-dimer, CRP, ESR, ferritin, NTproBNP and LD. |
| Secondary | Change from baseline in dysfunctional breathing patterns over time | Baseline and days 16, 45 and 90 | The effect of oral administration of nirmatrelvir/ritonavir on dysfunctional breathing patterns. Change from baseline in Njimegen questionnaire. |
| Other | Change from baseline in relationships between genotypes and immune function over time | At baseline and day 16 | The effect of oral administration of nirmatrelvir/ritonavir on the relationship between genotypes and immune function at the molecular level. Circulating protein levels adjusted for DNA-variants. |
| Other | Change from baseline in immune cell function over time | At baseline and day 16 | The effect of oral administration of nirmatrelvir/ritonavir on changes in immune cell function as assessed by high-dimensional cytometry. |
| Other | Change from baseline in persistence of SARS-CoV-2 virus over time | At baseline and day 16 | The effect of oral administration of nirmatrelvir/ritonavir on persistence of SARS-CoV-2 virus as measured by: Protein profiling using Olink Explore Inflammation panel. Nucleosome-profiling (using Volition) and circulating spike (using SIMOA™, Quanterix). PBMC profiling for scTCR-sequencing (using BD Rhapsody) with assessment of Super-Ag-mediated T-cell activation. Immune system signatures associated with disease states using RNA-sequencing of stabilized whole blood (PaxGene). |
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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