Trial · NCT04933799
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Worsening based on the NIAID Ordinal scale | 29 days | Proportion of subjects worsened at end of treatment (Day 29), as defined by categories 7 and 8 in the 8-point NIAID scale of disease severity. 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen\*. 3. Hospitalized, not requiring supplemental oxygen\* - no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen\* - requiring ongoing medical care (COVID-19 related or otherwise). 5. Hospitalized, requiring supplemental oxygen\*. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices\*\*. 7. Hospitalized, on invasive mechanical ventilation or ECMO. 8. Death. * For subjects on chronic home O2 supplementation (pre-morbid state), supplemental O2 is defined as ≥ home O2 requirement. * Use of non-invasive ventilation for chronic conditions (eg, Obstructive sleep apnea \[OSA\]) is not applicable. |
| Secondary | Improvement based on the NIAID Ordinal scale | 29 days | Proportion of subjects improved at end of treatment (Day 29), as defined by categories 1, 2, 3, and 4 in the 8-point NIAID ordinal scale of disease severity. |
| Secondary | Recovered based on the NIAID Ordinal scale | 29 days | Proportion of subjects recovered at end of treatment (Day 29), as defined by categories 1, 2, and 3 in the 8-point NIAID ordinal scale of disease severity. |
| Secondary | mortality | 29 days | All-cause mortality at Day 29 |
| Secondary | mortality | 61 days | All-cause mortality at Days 61 |
| Secondary | Time to clinical improvement based on the NIAID Ordinal scale | 29 days | Time to clinical improvement (defined as an at least 1-point decrease on the 8-point NIAID ordinal scale of disease severity). |
| Secondary | Time to worsening based on the NIAID Ordinal scale | 29 days | Time to worsening (defined as an at least 1-point increase on the 8-point NIAID ordinal scale of disease severity) |
| Secondary | Percentage of subjects in each category of ordinal scale of disease severity | 29 days | Percentage of subjects in each category of the 8-point NIAID ordinal scale of disease severity at Days 3, 5, 8, 11, 15, 22, and 29 |
| Secondary | Change in disease severity based on the NIAID Ordinal scale | 29 days | Change in the 8-point NIAID ordinal scale of disease severity from Day 1 to Days 3, 5, 8, 11, 15, 22, and 29, as available. Higher score means worsening outcomes. |
| Secondary | mechanical ventilatory support | 29 days | Proportion of subjects that have required mechanical ventilatory support through Day 29. |
| Secondary | Safety assessment by reporting of AEs | 29 days | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Secondary | subjects alive with resolution of respiratory insufficiency | 29 days | Proportion of subjects alive with resolution of respiratory insufficiency (defined as not requiring supplemental oxygen to maintain oxygen saturation by pulse oximetry \[SpO2\] \>94% while breathing room air) at Day 29. |
| Secondary | subjects alive with resolution of respiratory insufficiency | 61 days | Proportion of subjects alive with resolution of respiratory insufficiency (defined as not requiring supplemental oxygen to maintain oxygen saturation by pulse oximetry \[SpO2\] \>94% while breathing room air) at Days 61. |
| Other | Change from baseline in inflammatory parameters | 29 days | Change from baseline in inflammatory parameters (eg, high-sensitivity C-reactive protein \[hsCRP\], procalcitonin, ferritin, D-dimers, lactate dehydrogenase \[LDH\], fibrinogen, prothrombin time/partial thromboplastin time \[PT/PTT\], and troponin) in peripheral blood. • Linear mixed effects model that utilizes the longitudinal measurements will be used. The model will include fixed effects for baseline measurements, treatment, visit/time and treatment by visit/time interaction, age group, remdesivir use. |
| Other | cytokine panel. Units of measurement for all cytokines in the panel is pg/ml | 29 days | Change from baseline in cytokine panel (interferon\[IFN\]-gamma, interleukin \[IL\]-1 Beta , IL 2, IL 4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17, tumor necrosis factor alpha \[TNF alpha \], IL-2R \[sCD25\]), as available in peripheral blood.• Linear mixed effects model that utilizes the longitudinal measurements will be used. The model will include fixed effects for baseline measurements, treatment, visit/time and treatment by visit/time interaction, age group, remdesivir use. |
| Other | SARS-CoV-2 viral load | 29 days | Change from baseline in SARS-CoV-2 viral load (in nasopharyngeal swabs, blood, and/or saliva), as available |
| Other | ICU admission | 29 days | Proportion of subjects that have required ICU admission |
| Other | mechanical ventilation | 29 days | Duration (days) of mechanical ventilation. |
| Other | Ventilator free | 29 days | Ventilator free days. |
| Other | Pharmacokinetics of PF-06650833 | 15 days | Blood samples for analysis of PF-06650833 exposure will be collected at baseline (before the first dose), and at trough before the second dose (if applicable), and at trough on Days 8 and 15, as available. |
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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