Status:
COMPLETED
Study of Open Label Losartan in COVID-19
Lead Sponsor:
University of Kansas Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 eligibilit...
Detailed Description
This is an open label, phase 1 clinical trial to evaluate the safety of losartan in respiratory failure due to COVID-19. Clinical Trial setup: Detailed inclusion and exclusion criteria are listed be...
Eligibility Criteria
Inclusion
- 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 \<300 OR tachypnea (respiratory rate ≥24 breaths/min). Criteria to be met within 48 hours prior to Day 0.
- Other concomitant medications such as antivirals and hydroxychloroquine are allowed.
- Participants prescribed standard of care (SOC) losartan (25mg QD) within 48 hours of consenting may be considered for enrollment if eligibility criteria are met based on EMR data assessment, i.e. no other ARB or ACE prior to SOC medication administration. If participant is eligible and signs consent form, investigational losartan 25mg QD will be ordered to replace SOC prescription on the following scheduled dose.
Exclusion
- Pregnancy.
- Respiratory failure due to a process other than COVID-19.
- Intolerance to ARBs.
- Previous treatment with an ARB or ACE inhibitor (see exception in inclusion criteria).
- Current chronic use of medication with known interactions with losartan including NSAIDs (intermittent prior use is acceptable), potassium supplementation aliskiren.
- Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic recorded on at least two readings 30 min apart.
- Need for vasopressors, unless norepinephrine ≤0.1 µg/kg/min
- Hyperkalemia (serum K+ \>5.5 mM).
- Known cardiac failure (left ventricular ejection fraction ≤35%), renal insufficiency (Cockcroft-Gault \<30 mL/min/1.73 m2 or urinary output \<20 mL/h), hepatic failure (LFTs \> 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.
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04335123
Start Date
April 4 2020
End Date
August 17 2020
Last Update
August 2 2024
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160