Trial · NCT04663737
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | From randomization (Day 1) to Day 60 | To assess adverse events associated with the administration of CX-4945 orally, twice daily to patients with moderate COVID-19. The occurrence of overall AEs in the two treatment groups are summarized. |
| Secondary | Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group | First 14 days of the study. | To compare the number of days to clinical recovery specifically associated with COVID-19 in the CX-4945 treatment group as compared to the control arm by Day 14 of the study. |
| Secondary | Anti-Viral Activity of CX-4945 | Quantitative changes in viral load from Day 1 to Day 28. | To evaluate preliminary evidence of anti-viral activity of CX-4945 as compared to the control arm. |
| 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. | To evaluate the maximum plasma concentration of CX-4945 when given at 1000 mg BID PO (Experimental Arm taking CX-4945 only i.e. Group A). |
| 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. | To evaluate the time to maximum observed plasma concentration of CX-4945 when given at 1000 mg BID PO (Experimental Arm taking CX-4945 only i.e. Group A). |
| 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. | To evaluate the area under the concentration-time curve \[AUC0-6\] of CX-4945 when given at 1000 mg BID PO (Experimental Arm taking CX-4945 only i.e. Group A). |
| 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 | Between the experimental arm with CX-4945 and the control arm, moderate COVID-19 patients' health status will be evaluated in terms of all-cause mortality. Mortality status and cause will be assessed by study staff and the information will be documented on a Clinical Status questionnaire. The data collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in all-cause mortality between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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 | Between the experimental arm with CX-4945 and the control arm, moderate COVID-19 patients' health status will be evaluated in terms of the number of respiratory failures. Respiratory failures will be assessed by study staff and the information will be documented on a Clinical Status questionnaire. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in number of respiratory failures between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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 | Between the experimental arm with CX-4945 and the control arm, patients will be evaluated in terms of the number of subjects hospitalized in each treatment group. The number of subjects hospitalized will be assessed and the information will be documented on a clinical status questionnaire. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in number of subjects hospitalized between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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 | Between the experimental arm with CX-4945 and the control arm, patients will be evaluated in terms of time to oxygen saturation level normalization. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in time to oxygen saturation level normalization between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. Best Case Scenario = Days to first response for responder, = Days to last observation for non-responder (censored); Worst Case Scenario = Days to first response for responder, = Days to planned last observation date (31 for EQ-5D-5L and SARS-COV-2 Viral Clearance at visit 7, 45 for others at visit 8) for non-responder (censored); Days to first response = date of first response - the first treatment date/time + 1 Days to last observation = date of last evaluation - the first treatment date/time + 1 For Arm SOC, the first treatment date is the date of visit 2. |
| 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 | Between the experimental arm with CX-4945 and the control arm, proportion of subjects with disease progression or improvement in health status occurring from Randomization (Day 1) to Day 28 will be evaluated. Disease progression is defined as change in subject health status assessment from item 7 to items 1- 6 and health improvement -as change from item 7 to item 8, evaluated by the ordinal NIAID 8- point Clinical Progression Outcomes scale - collected at every visit from randomization (Day 1) through Day 45. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in clinical status between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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. | Changes in the total score for Q1\~Q5 of the EQ-D5-5L (used as an indicator of symptom improvement) from Baseline (Day 1) to Day 8, 14, 28 were evaluated. The 5-level EQ-5D version (EQ-5D-5L) was used to assess five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Four times during the study (baseline, Day 8, Day 14 and Day 28) the patients were asked to complete health status survey by answering 6 questions about their health and quality of life. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients were also asked to assess their overall health status by selecting a number between 1 and 100 to describe the condition of their health, 100 being the best imaginable. |
| 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. | Changes in the Imaginable Health Status of the EQ-D5-5L (used as an indicator of symptom improvement) from Baseline (Day 1) to Day 8, 14, 28 were evaluated. The 5-level EQ-5D version (EQ-5D-5L) was used to assess five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Four times during the study (baseline, Day 8, Day 14 and Day 28) the patients were asked to complete health status survey by answering 6 questions about their health and quality of life. Patients were also asked to assess their overall health status by selecting a number between 1 and 100 to describe the condition of their health, 100 being the best imaginable. |
| 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. | Labs to evaluate changes in plasma IL-6 (interleukin-6 in ng/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma IL-6 levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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. | Labs to evaluate changes in plasma CRP (C-reactive protein in mg/DL) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma CRP levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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. | Labs to evaluate changes in plasma LDH (lactic acid dehydrogenase in U/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma LDH levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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. | Labs to evaluate changes in plasma CPK (creatine phosphokinase in U/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma CPK levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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. | Labs to evaluate changes in plasma ferritin (μg/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma ferritin levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
| 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. | Labs to evaluate changes in plasma D-dimer (μg/mL) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma D-dimer levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04663737/registered