Trial · NCT04335123
Study of Open Label Losartan in COVID-19
NCT04335123, Phase 1, Completed, University of Kansas Medical Center; results first posted 2024-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Open Label Losartan in COVID-19. Trials, record NCT04335123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04335123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Open Label Losartan in COVID-19
- NCT number
- NCT04335123
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- University of Kansas Medical Center
- Conditions
- COVID-19
- Interventions
- Losartan
- First posted
- 2020-04-06
- Last updated
- 2024-08-02
- Results first posted
- 2024-08-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE | 14 days of losartan treatment | Safety will be reported based on Protocol defined AEs. For the purpose of this protocol, an AE will be defined as as any untoward medical occurrence in a subject during the study listed under DMSB - Anticipated Adverse Events and Grading Scale section of this protocol as well as safety monitoring data listed on protocol table 1 as well as stoppage criteria for losartan. The event does not necessarily have a causal relationship with the treatment. AEs will be collected for both study groups, treatment and control from the time the ICF is signed until the subject completes study participation. |
| Secondary | Number of Days on Supplemental Oxygen in Respiratory Failure Due to COVID-19 | 14 days of losartan treatment | Number of days on supplemental oxygen in respiratory failure due to COVID-19 |
| Secondary | Number of Participants With Mechanical Ventilation Use | 14 days of losartan treatment | Number of participants with mechanical ventilation use |
| Secondary | Days on Mechanical Ventilation | 14 days of losartan treatment | Days on mechanical ventilation |
| Secondary | Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula Use | 14 days of losartan treatment | Number of participants with non-invasive positive pressure ventilation or heated high flow nasal cannula use |
| Secondary | Days on Non-invasive Positive Pressure Ventilation or High Flow Nasal Cannula | 14 days of losartan treatment | Days on non-invasive positive pressure ventilation or high flow nasal cannula |
| Secondary | Number of Participants With Transfer to ICU From Non-ICU Hospital Bed | 14 days of losartan treatment | Number of participants with transfer to ICU from non-ICU hospital bed |
| Secondary | ICU Length of Stay (Days) | 14 days of losartan treatment | ICU length of stay (days) |
| Secondary | in Hospital Mortality Rate | 14 days after study enrollment | in hospital mortality rate |
| Secondary | Hospital Length of Stay (Days) | from enrollment through hospital discharge | Hospital length of stay (days) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE | 14 days of losartan treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Days on Supplemental Oxygen in Respiratory Failure Due to COVID-19 | 14 days of losartan treatment | days | MEDIAN | |
| SECONDARY | Number of Participants With Mechanical Ventilation Use | 14 days of losartan treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Days on Mechanical Ventilation | 14 days of losartan treatment | days | MEDIAN | |
| SECONDARY | Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula Use | 14 days of losartan treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Days on Non-invasive Positive Pressure Ventilation or High Flow Nasal Cannula | 14 days of losartan treatment | days | MEDIAN | |
| SECONDARY | Number of Participants With Transfer to ICU From Non-ICU Hospital Bed | 14 days of losartan treatment | Data regarding transfer to ICU was not collected for any participants during study period and thus not reported. | ||
| SECONDARY | ICU Length of Stay (Days) | 14 days of losartan treatment | days | MEDIAN | |
| SECONDARY | in Hospital Mortality Rate | 14 days after study enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Length of Stay (Days) | from enrollment through hospital discharge | days | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE | Open Label Losartan | 24 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE | External Controls | 44 | Participants | ||
| Number of Days on Supplemental Oxygen in Respiratory Failure Due to COVID-19 | Open Label Losartan | 4 | Inter-Quartile Range 2 to 6 | days | |
| Number of Days on Supplemental Oxygen in Respiratory Failure Due to COVID-19 | External Controls | 4 | Inter-Quartile Range 0 to 9 | days | |
| Number of Participants With Mechanical Ventilation Use | Open Label Losartan | 2 | Participants | ||
| Number of Participants With Mechanical Ventilation Use | External Controls | 9 | Participants | ||
| Days on Mechanical Ventilation | Open Label Losartan | 0 | Inter-Quartile Range 0 to 0 | days | |
| Days on Mechanical Ventilation | External Controls | 11 | Inter-Quartile Range 8 to 14 | days | |
| Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula Use | Open Label Losartan | 6 | Participants | ||
| Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula Use | External Controls | 3 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label Losartan | 34 | |
| Overall Study | STARTED | External Control | 46 | |
| Overall Study | COMPLETED | Open Label Losartan | 30 | |
| Overall Study | COMPLETED | External Control | 46 | |
| Overall Study | NOT COMPLETED | Open Label Losartan | 4 | |
| Overall Study | NOT COMPLETED | External Control | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Low hemoglobin | Blood and lymphatic system disorders | Open Label Losartan | 15 | 30 | 15 |
| other | Low hemoglobin | Blood and lymphatic system disorders | External Controls | 32 | 46 | 32 |
| other | Elevated AST | Hepatobiliary disorders | Open Label Losartan | 11 | 30 | 11 |
| other | Elevated AST | Hepatobiliary disorders | External Controls | 30 | 46 | 30 |
| other | Elevated ALT | Hepatobiliary disorders | Open Label Losartan | 12 | 30 | 12 |
| other | Elevated ALT | Hepatobiliary disorders | External Controls | 23 | 46 | 23 |
| other | Elevated creatinine | Renal and urinary disorders | Open Label Losartan | 9 | 30 | 9 |
| other | Elevated creatinine | Renal and urinary disorders | External Controls | 12 | 46 | 12 |
| other | hypotension | Vascular disorders | Open Label Losartan | 8 | 30 | 8 |
| other | hypotension | Vascular disorders | External Controls | 14 | 46 | 14 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Losartan | 1 | 30 |
| Total, all-cause mortality | External Controls | 3 | 46 |
| Total, other adverse events | Open Label Losartan | 24 | 30 |
| Total, other adverse events | External Controls | 44 | 46 |
| Total, serious adverse events | Open Label Losartan | 0 | 30 |
| Total, serious adverse events | External Controls | 0 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32658300 | DERIVED |
Source PubMed
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Open Label Losartan vs External Controls: Number of Participants With Increase of Supplemental Oxygen Needs From Baseline. | Trial comparisons |
Open Label Losartan vs External Controls: Number of Participants With Medications With Possible Antiviral Activity (Hydroxychloroquine, Lopinavir/Ritonavir, Ribavirin or Remdesivir) or Adjunctive Therapy Use (e.g., Tocilizumab) | Trial comparisons |
| Open Label Losartan vs External Controls: Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE | Trial comparisons |
| Open Label Losartan vs External Controls: in Hospital Mortality Rate | Trial comparisons |
| Open Label Losartan vs External Controls: Number of Participants With Mechanical Ventilation Use | Trial comparisons |
| Open Label Losartan vs External Controls: Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula Use | Trial comparisons |
| Open Label Losartan vs External Controls: Number of Participants With Extracorporeal Membrane Oxygenation Use | Trial comparisons |
| Open Label Losartan vs External Controls: Number of Participants With Intolerance to High Dose (50mg) Losartan After Tolerating 25mg | Trial comparisons |
| Open Label Losartan vs External Controls: deaths from any cause | Trial comparisons |
| Open Label Losartan vs External Controls: Cumulative Number of Participants With of Severe Adverse Events | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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.
Data dates
The day each source was copied for this release.
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 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/NCT04335123
GET https://conductscience.org/api/trials/v1/NCT04335123/results?page=2