Trial · NCT04663737
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | From randomization (Day 1) to Day 60 | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group | First 14 days of the study. | 2 patients in Group A, 3 patients in Group B were censored from this analysis per protocol. | Days | MEDIAN |
| SECONDARY | Anti-Viral Activity of CX-4945 | Quantitative changes in viral load from Day 1 to Day 28. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Maximum Plasma Concentration [Cmax] of CX-4945 | Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose. | Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration [Tmax] of CX-4945 | Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose. | Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A. | h | MEAN |
| SECONDARY | Area Under the Concentration-Time Curve [AUC0-6] of CX-4945 | Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose. | Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A. | h*ng/mL | MEAN |
| SECONDARY | Clinical Benefit of CX-4945 i.e. All-cause Mortality Status - the Number of Deaths Occurred in Each Treatment Group From Randomization (Day 1) Through Day 60 | From Randomization (Day 1) through Day 60 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Number of Respiratory Failures Occurred in Each Treatment Group From Randomization (Day 1) Through Day 45 | From Randomization (Day 1) through Day 45 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Number of Subjects Hospitalized in Each Treatment Group From Randomization (Day 1) to Day 45 | From Randomization (Day 1) to Day 45 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Number of Days to Normalization of Oxygen Saturation Level Measured by Pulse Oximeter at Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45 and Categorized as <96% Versus ≥96%. | Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | days | MEAN |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. | From Randomization (Day 1) to Day 28 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Changes in the Total Score for Q1~Q5 of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. | From randomization (Day 1) to Day 8, Day 14 and Day 28. | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | score on a scale | MEAN |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Changes in the Imaginable Health Status of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. | From randomization (Day 1) to Day 8, Day 14 and Day 28. | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | score on a scale | MEAN |
| SECONDARY | CX-4945 Inflammatory Marker Outcomes i.e. Plasma IL-6 | Changes in plasma IL-6 level from Randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14. | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | ng/L | MEAN |
| SECONDARY | CX-4945 Inflammatory Marker Outcomes i.e. Plasma CRP | Changes in CRP from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14. | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | mg/dL | MEAN |
| SECONDARY | CX-4945 Inflammatory Marker Outcomes i.e. Plasma LDH | Changes in LDH from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14. | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | U/L | MEAN |
| SECONDARY | CX-4945 Inflammatory Marker Outcomes i.e. Plasma CPK | Changes in CPK from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14. | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | U/L | MEAN |
| SECONDARY | CX-4945 Inflammatory Marker Outcomes i.e. Plasma Ferritin | Changes in ferritin from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14. | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | μg/L | MEAN |
| SECONDARY | CX-4945 Inflammatory Marker Outcomes i.e. Plasma D-Dimer | Changes in D-dimer from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14. | Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization. | μg/mL | MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04663737/outcomes