Trial · NCT04393246
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure | up to Day 14 | Number of days taken for occurrence of one of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) \<15 ml /min/1.73m\^2), haemofiltration or dialysis |
| Secondary | Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: IL-6 | 14 days | Change in patient blood levels of IL-6 compared to baseline, measured in pg/mL |
| Secondary | Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: ferritin | 14 days | Change in patient blood levels of ferritin compared to baseline, measured in ng/mL |
| Secondary | Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: c-reactive protein (CRP) | 14 days | Change in patient blood levels of CRP compared to baseline, measured in mg/L |
| Secondary | Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: D-dimer | 14 days | Change in patient blood levels of D-dimer compared to baseline, measured in ng/mL |
| Secondary | Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: neutrophil/lymphocyte ratio | 14 days | Change in patient blood levels of neutrophil/lymphocyte ratio compared to baseline |
| Secondary | Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: lactate dehydrogenase (LDH) | 14 days | Change in patient blood levels of lactate dehydrogenase (LDH) compared to baseline, measured in U/L |
| Secondary | Change in clinical status as assessed on 7-point ordinal scale compared to baseline | 14 days | The clinical status of the patients is assessed using 7-point ordinal scale as follows: 1 = Death, 2 = Mechanical ventilation, 3 = Non-invasive or high flow oxygen, 4 = Low flow oxygen, 5 = Hospitalised - no oxygen, 6 = Discharged - normal activities not resumed, 7 = Discharged - normal activities resumed |
| Secondary | Time to each of the individual endpoints of the composite primary outcome measure | 14 days | Number of days taken for occurrence of each of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) \<15 ml /min/1.73m\^2), haemofiltration or dialysis |
| Secondary | Proportion of patients with adverse events of special interest in each treatment arm | 14 days | The proportion of patients in each treatment arm that experience adverse events of special interest, defined as: Diabetic ketoacidosis in patients on Ambrisentan \& Dapagliflozin, New peripheral oedema in patients on Ambrisentan \& Dapagliflozin arm |
| Secondary | Time to Sp02 >94% on room air | 14 days | The time taken to achieve blood oxygen saturation levels above 94% in patients on room air, measured in hours/days (chronically hypoxic individuals will be excluded from this analysis) |
| Secondary | Time to first negative SARS-CoV2 PCR | 14 days | The amount of time between a patient's first positive SARS-CoV2 PCR test and a patient's first negative SARS-CoV2 PCR test, measured in days |
| Secondary | Duration of oxygen therapy | 14 days | The duration of oxygen therapy given to a patient, measured in days |
| Secondary | Duration of hospitalisation | 14 days | The duration of hospitalisation of a patient, measured in days |
| Secondary | All-cause mortality at day 28 | 28 days | The number of deaths recorded at 28 days irrespective of the cause |
| Secondary | Time to clinical improvement | 14 days | The time to clinical improvement for a patient, defined as: \>2 point improvement from Day 1 on the 7-point ordinal scale, measured in days |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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GET https://conductscience.org/api/trials/v1/NCT04393246/registered