18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AEPrimary· 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.
Group
Value
95% CI
Open Label Losartan
24
External Controls
44
Number of Days on Supplemental Oxygen in Respiratory Failure Due to COVID-19Secondary· 14 days of losartan treatment
Number of days on supplemental oxygen in respiratory failure due to COVID-19
Group
Value
95% CI
Open Label Losartan
4
2 – 6
External Controls
4
0 – 9
Number of Participants With Mechanical Ventilation UseSecondary· 14 days of losartan treatment
Number of participants with mechanical ventilation use
Group
Value
95% CI
Open Label Losartan
2
External Controls
9
Days on Mechanical VentilationSecondary· 14 days of losartan treatment
Days on mechanical ventilation
Group
Value
95% CI
Open Label Losartan
0
0 – 0
External Controls
11
8 – 14
Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula UseSecondary· 14 days of losartan treatment
Number of participants with non-invasive positive pressure ventilation or heated high flow nasal cannula use
Group
Value
95% CI
Open Label Losartan
6
External Controls
3
Days on Non-invasive Positive Pressure Ventilation or High Flow Nasal CannulaSecondary· 14 days of losartan treatment
Days on non-invasive positive pressure ventilation or high flow nasal cannula
Group
Value
95% CI
Open Label Losartan
0
0 – 0
External Controls
5
3.5 – 7.5
ICU Length of Stay (Days)Secondary· 14 days of losartan treatment
ICU length of stay (days)
Group
Value
95% CI
Open Label Losartan
0
0 – 11.5
External Controls
10
7.5 – 13.5
in Hospital Mortality RateSecondary· 14 days after study enrollment
in hospital mortality rate
Group
Value
95% CI
Open Label Losartan
1
External Controls
3
Hospital Length of Stay (Days)Secondary· from enrollment through hospital discharge
Hospital length of stay (days)
Group
Value
95% CI
Open Label Losartan
9
6 – 14.75
External Controls
7
4 – 13.5
Cumulative Number of Participants With of Severe Adverse EventsSecondary· 14 days of losartan treatment
Cumulative number of participants with severe adverse events
Group
Value
95% CI
Open Label Losartan
0
External Controls
0
Number of Participants With Increase of Supplemental Oxygen Needs From Baseline.Secondary· 14 days of losartan treatment
Number of participants with increase in supplemental oxygen needs from baseline.
Group
Value
95% CI
Open Label Losartan
4
External Controls
12
Number of Participants With Medications With Possible Antiviral Activity (Hydroxychloroquine, Lopinavir/Ritonavir, Ribavirin or Remdesivir) or Adjunctive Therapy Use (e.g., Tocilizumab)Secondary· 14 days of losartan treatment
Number of participants with medications with possible antiviral activity (hydroxychloroquine, lopinavir/ritonavir, ribavirin or remdesivir) or adjunctive therapy use (e.g., tocilizumab)
Group
Value
95% CI
Open Label Losartan
30
External Controls
30
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrollment to hospital discharge, up to day 14..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open label, phase 1 clinical trial to evaluate the safety of losartan in respiratory failure due to COVID-19.
Briefly, 34 patients with COVID-19 and respiratory failure who meet eligibility criteria and agree to participation in the study will be placed on losartan 25 mg daily on study day 0. If parameters are met the dose of losartan will be increased to 50 mg once daily on study day 3. Participants will continue losartan until they experience resolution of respiratory failure (normal oxygen levels on room air), are discharged from the hospital, meet stoppage criteria (detailed below) or complete 14 days of therapy.
Patients and/or surrogate decision maker who do not give consent to treatment will be asked to allow collection of data from their medical record for use as a control group. We will also collect medical information relating to safety criteria on historical controls treated at the University of Kansas Hospital in the 30 days prior to the study start date and during the study period.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06491940 — Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan
· NA
· not yet recruiting
NCT06333522 — Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty
· Phase 4
· withdrawn
NCT06150560 — A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
· Phase 3
· recruiting
NCT06108063 — Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
· Phase 1, PHASE2
· recruiting
NCT06329050 — The Effects of Losartan on Attention Control: An Eye-tracking Study
· NA
· recruiting
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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· Phase 1
· active not recruiting
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· Phase 3
· active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
· Phase 1
· recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
· Phase 2
· recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A
· Phase 3
· active not recruiting
Other University of Kansas Medical Center trials
Trials by the same sponsor.
NCT06636214 — Adapting Changing Talk: Online (CHATO) to CHATO-Inclusive
· NA
· not yet recruiting
NCT07528963 — KanSurvive 2.0: Testing Enhanced Models of Cancer Survivorship Care for Rural Cancer Survivors in Primary Care Practice
· NA
· enrolling by invitation
NCT07463755 — Low-Fidelity Driving Simulator Training in Parkinson's Disease.
· NA
· not yet recruiting
NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives
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· recruiting
NCT07491510 — Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Kansas Medical Center
Last refreshed: 2 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04335123.