Phase 1
Completed N=80
Study of Open Label Losartan in COVID-19
Source: ClinicalTrials.gov NCT04335123 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE — 24; 44 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events as Assessed by Protocol Definition of AE |
24; 44 | — |
| SECONDARY Number of Days on Supplemental Oxygen in Respiratory Failure Due to COVID-19 |
4; 4 | — |
| SECONDARY Number of Participants With Mechanical Ventilation Use |
2; 9 | — |
| SECONDARY Days on Mechanical Ventilation |
0; 11 | — |
| SECONDARY Number of Participants With Non-invasive Positive Pressure Ventilation or Heated High Flow Nasal Cannula Use |
6; 3 | — |
| SECONDARY Days on Non-invasive Positive Pressure Ventilation or High Flow Nasal Cannula |
0; 5 | — |
| SECONDARY Number of Participants With Transfer to ICU From Non-ICU Hospital Bed |
— | — |
| SECONDARY ICU Length of Stay (Days) |
0; 10 | — |
| SECONDARY in Hospital Mortality Rate |
1; 3 | — |
| SECONDARY Hospital Length of Stay (Days) |
9; 7 | — |
| SECONDARY Cumulative Number of Participants With of Severe Adverse Events |
0; 0 | — |
| SECONDARY Number of Participants With Increase of Supplemental Oxygen Needs From Baseline. |
4; 12 | — |
| SECONDARY Number of Participants With Medications With Possible Antiviral Activity (Hydroxychloroquine, Lopinavir/Ritonavir, Ribavirin or Remdesivir) or Adjunctive Therapy Use (e.g., Tocilizumab) |
30; 30 | — |
| SECONDARY Number of Participants With Extracorporeal Membrane Oxygenation Use |
0; 0 | — |
| SECONDARY Number of Participants With Renal Replacement Therapy Use |
— | — |
| SECONDARY Number of Participants With Intolerance to High Dose (50mg) Losartan After Tolerating 25mg |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age >18 years admitted to the University of Kansas Health System.
- Confirmation of infection with SARS-CoV-2 by PCR testing.
- Hypoxic respiratory failure Requiring mechanical ventilation or oxygen OR a SpO2 ≤94% on room air or a PaO2/FiO2 (P/F) ratio 5.5 mM).
- Known cardiac failure (left ventricular ejection fraction ≤35%), renal insufficiency (Cockcroft-Gault 5x normal upper limit).
- Known renal artery stenosis.
- Neurological, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study.
- On another interventional trial (including one for COVID-19) that excludes participation.
Data sourced from ClinicalTrials.gov (NCT04335123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.