Phase 2
N=205
Losartan for Patients With COVID-19 Requiring Hospitalization
Corona Virus Infection · Acute Respiratory Distress Syndrome · SARS-CoV Infection
Bottom Line
View on ClinicalTrials.gov: NCT04312009 ↗Enrolled (actual)
205
Serious AEs
32.2%
Results posted
Jun 2022
Primary outcome: Primary: Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days — 281.4; 260.9 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Losartan (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days |
281.4; 260.9 | — |
| SECONDARY Daily Hypotensive Episodes |
0.048; 0.119 | — |
| SECONDARY Proportion of Participants Requiring Vasopressors for Hypotension |
0.106; 0.198 | — |
| SECONDARY Proportion of Participants Experiencing Acute Kidney Injury |
0.106; 0.119 | — |
| SECONDARY Oxygen Saturation / Fractional Inhaled Oxygen (S/F) |
357.4; 331.5 | — |
| SECONDARY 28-Day Mortality |
0.087; 0.11 | — |
| SECONDARY 90-Day Mortality |
0.106; 0.11 | — |
| SECONDARY ICU Admission |
0.272; 0.36 | — |
| SECONDARY Number of Ventilator-Free Days |
18.4; 18.1 | — |
| SECONDARY Number of Therapeutic Oxygen-Free Days |
24.6; 23.6 | — |
| SECONDARY Number of Vasopressor-Free Days |
9.4; 8.7 | — |
| SECONDARY Length of Hospital Stay |
5.9; 7.1 | — |
| SECONDARY Disease Severity Rating |
4.3; 4.2 | — |
| SECONDARY Change in Viral Load by Nasopharyngeal Swab Day 15 |
-4.2; -4.8 | — |
Summary
This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.
Eligibility Criteria
Inclusion Criteria
- Presumptive positive laboratory test for Covid-19 based on local laboratory standard
- Age greater than or equal to 18 years of age
- Admission to the hospital with a respiratory SOFA >=1 and increased oxygen requirement compared to baseline among those on home O2
- Randomization within 48 hours of presentation of hospital admission or within 48 hours of a positive test result, whichever is later
Exclusion Criteria
- Randomization > 48 hours of admission order or positive test result, whichever is later
- Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB)
- Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to angioedema
- Pregnant or breastfeeding
- Lack of negative urine or serum pregnancy test
- Not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g. medroxyprogesterone acetate / Depo-Provera), subcutaneous contraceptive (e.g. Nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study period; use of condoms or agree to abstain from sexual intercourse during the study. All women of child bearing age enrolled in this fashion will be informed of the teratogenic risks. If enrolled under LAR, they will be informed of the risks after regaining capacity.
- Patient reported history or electronic medical record history of kidney disease, defined as:
- Any history of dialysis
- History of chronic kidney disease stage IV
- Estimated Glomerular Filtration Rate (eGFR) of 3 times the upper limit of normal measured within 24 hours prior to randomization
- Potassium >5.0 within 24 hours prior to randomization unless a repeat value was <=5.0
- Treatment with aliskiren
- Inability to obtain informed consent from participant or legally authorized representative
- Enrollment in another blinded randomized clinical trial for COVID
Data sourced from ClinicalTrials.gov (NCT04312009). 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.