Trial · NCT04640168
Outcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 44
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) | Day 1 through Day 29 | The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4. | Proportion of participants | NUMBER |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | Units/Liter (U/L) | MEAN |
| SECONDARY | Change From Baseline in Aspartate Aminotransferase (AST) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | U/L | MEAN |
| SECONDARY | Change From Baseline in C-reactive Protein (CRP) | Days 1, 3, 5, 8, 11, 15 and 29 | The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, the earliest post-treatment dose was used. Participants from sites reporting high sensitivity CRP were excluded. | milligrams/liter (mg/L) | MEAN |
| SECONDARY | Change From Baseline in Creatinine | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in D-dimer Concentration | Days 1, 3, 5, 8, 11, 15 and 29 | The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used. | mg/L fibrinogen-equivalent units (FEU) | MEAN |
| SECONDARY | Change From Baseline in Glucose | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | grams/deciliter (g/dL) | MEAN |
| SECONDARY | Change From Baseline in Platelets | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | ratio | MEAN |
| SECONDARY | Change From Baseline in Total Bilirubin | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in White Blood Cell Count (WBC) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Neutrophils | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Lymphocytes | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Monocytes | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Basophils | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Eosinophils | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | Day 1 through Day 29 | The safety population includes all participants with available data post baseline, analyzed as treated. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Serious Adverse Events (SAEs) | Day 1 through Day 29 | The safety population includes all participants with available data post baseline, analyzed as treated. | percentage of participants | NUMBER |
| SECONDARY | Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) | Day 1 through Day 29 | The analysis population is restricted to randomized participants who were on invasive ventilation. | Days | MEDIAN |
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/NCT04640168/outcomes