Trial · NCT04579393
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 | Number of Participants With at Least 1 Serious Adverse Event | Day 29 | Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death. |
| Secondary | Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | day 29 | Time to sustained recovery determined by ordinal scale score of 3 or less and defined as time to recovery \[either discharge from the hospital or hospitalization for infection control reasons only\], with the recovery status sustained through day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Secondary | Number of Participants Who Progress to Mechanical Ventilation | day 29 | Number of participants who progress to mechanical ventilation by day 29 |
| Secondary | Number of Participants With Cumulative Clinical Endpoint of Death | day 14, day 28, day 60 | Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60 |
| Secondary | Number of Grade 3 and 4 Adverse Events Through Day 60 | Day 60 | Number of Grade 3 and 4 AE through day 60 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death. |
| Secondary | Participant Score on Ordinal Scale | Day 15, Day 29 | Participant score on ordinal scale at day 15 and day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Secondary | Change in C-Reactive Protein Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter). |
| Secondary | Change in Fibrinogen Levels From Baseline. | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL). |
| Secondary | Change in D-Dimer Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter). |
| Secondary | Change in Ferritin Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter). |
| Secondary | Change in Interleukin 6 (IL6) Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL). |
| Secondary | Median Days Participants Were Admitted to Intensive Care Unit | Day 29 | Median days participants were admitted to Intensive Care Unit (ICU) by day 29 |
| Secondary | Relative Change in SpO2/FiO2 Ratio | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Relative change in PaO2/FiO2 or SpO2/FiO2 ratio. |
| Secondary | Change in SOFA Score From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in SOFA score from baseline (day 1). The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24. |
| Secondary | Median Days on Participants Received Supplemental Oxygen | day 29 | Median days on participants received supplemental oxygen through day 29 |
| Secondary | The Number of Participants That Experienced Acute Renal Failure | day 29 | The number of participants that experienced acute renal failure by day 29. Acute renal failure defined as increase in serum creatinine by ≥0.3mg/dL within 48 hours or increase in serum creatinine by ≥1.5 times baseline which is known or presumed to have occurred within the prior seven days. |
| Secondary | Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | day 29 | Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29 |
| Secondary | Change in Absolute Lymphocyte Count Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Absolute lymphocyte count blood levels from baseline. |
| Secondary | Change in Absolute Neutrophil Count Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Absolute neutrophil count blood levels from baseline. |
| Secondary | Change in Platelet Count Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Platelet count blood levels from baseline. |
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/NCT04579393/registered