Trial · NCT04393246
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms
NCT04393246, Phase 2, Phase 3, Completed, Cambridge University Hospitals NHS Foundation Trust
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms. Trials, record NCT04393246. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04393246
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms
- NCT number
- NCT04393246
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 454 participants, actual
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Conditions
- COVID-19
- Interventions
- EDP1815, Dapagliflozin, Ambrisentan, Standard of care
- First posted
- 2020-05-19
- Last updated
- 2023-07-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04393246
GET https://conductscience.org/api/trials/v1/NCT04393246/registered