Phase 2
Completed N=117
Losartan for Patients With COVID-19 Not Requiring Hospitalization
Corona Virus Infection · Acute Respiratory Distress Syndrome · SARS-CoV Infection
Source: ClinicalTrials.gov NCT04311177 ↗
Enrolled (actual)
117
Serious AEs
3.4%
Results posted
May 2022
Primary outcomePrimary: Percentage of Participants Admitted to the Hospital — 5.2; 1.7 percentage of participants
Summary
This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Admitted to the Hospital |
5.2; 1.7 | — |
| SECONDARY Change in PROMIS Dyspnea Scale |
-0.4; -0.5 | — |
| SECONDARY Change in SF-12 Physical Composite Score |
1.4; 0.2 | — |
| SECONDARY Change in SF-12 Mental Composite Score |
-0.1; -0.3 | — |
| SECONDARY Daily Maximum Temperature |
97.7; 97.8 | — |
| SECONDARY Count of Participants With an Emergency Department or Clinic Presentation |
10; 5 | — |
| SECONDARY Disease Severity Rating Day 15 |
5.8; 5.9 | — |
| SECONDARY Change in Viral Load by Nasopharyngeal Swab at Day 9 |
-3.8; -3.6 | — |
| SECONDARY Change in Viral Load by Nasopharyngeal Swab at Day 15 |
-3.7; -4 | — |
| SECONDARY Percentage of Patients Admitted to the Intensive Care Unit Within 15 Days |
1.7; 1.7 | — |
| SECONDARY Need for Oxygen Therapy at 15 Days |
1.7; 1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Positive laboratory test for COVID-19 based on local laboratory standard
- Age greater than or equal to 18 years of age
- One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (>101.5) or loss of taste / smell
Exclusion Criteria
- Randomization > 72 hours of meeting inclusion criteria
- Randomization > 7 days of symptom onset
- 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 women
- Females able to have children 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, condom use or abstinence during the study. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks.
- 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 within 3 months of randomization (if available in electronic medical record)
- Potassium >5.0 mmol/L (must have been measured within 1 month) of enrollment
- Concurrent treatment with aliskiren
- Inability to obtain informed consent
- Enrollment in another blinded randomized clinical trial for COVID
Data sourced from ClinicalTrials.gov (NCT04311177). 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.