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Corona Virus InfectionPhase 2NCT04312009

Losartan for Patients With COVID-19 Requiring Hospitalization

A Phase 2 study testing Losartan in people with Corona Virus Infection and Acute Respiratory Distress Syndrome, run by University of Minnesota at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Losartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
205 participants
Where
13 sitesUnited States
Study dates
13 Apr 2020to 1 Feb 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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 < 30ml/min/1.73 m2 at the time of randomization
  • Severe dehydration at the time of enrollment in the opinion of the investigator or bedside clinician
  • Most recent mean arterial blood pressure prior to enrollment <65 mmHg
  • Patient reported history or electronic medical record history of severe liver disease, defined as:
  • Cirrhosis
  • History of hepatitis B or C
  • Documented AST or ALT > 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • M Health Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • M Health Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • University of Florida Health Gainesville

    Gainesville, Florida, 32611

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • North Memorial Health Hospital

    Robbinsdale, Minnesota, 55422

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

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.

Being tested
Losartan, Placebo
Keywords
COVID-19, Corona Virus, SARS-COV-2
Medical subject headings
Coronavirus Infections, Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LosartanDrug

    Also called Cozaar

    Losartan; 50 mg daily; oral administration

  • PlaceboOther

    Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Study groups in NCT04312009
Study groupRoleWhat they receive
LosartanExperimentalParticipants in this arm will receive the study drug, Losartan.
Receives: Drug: Losartan
PlaceboPlacebo comparatorParticipants in this arm will receive a placebo treatment.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days

    Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.

    Measured: 7 days

Secondary outcomes (13)

  1. Daily Hypotensive Episodes

    Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.

    Measured: 10 days

  2. Proportion of Participants Requiring Vasopressors for Hypotension

    Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

    Measured: 10 days

  3. Proportion of Participants Experiencing Acute Kidney Injury

    Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

    Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.

    Measured: 10 days

  4. Oxygen Saturation / Fractional Inhaled Oxygen (S/F)

    Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The S/F ratio is unitless.

    Measured: 7 days

  5. 28-Day Mortality

    Outcome reported as the number of participants who have expired at 28 days post enrollment.

    Measured: 28 days

  6. 90-Day Mortality

    Outcome reported as the number of participants who have expired at 90 days post enrollment.

    Measured: 90 days

  7. ICU Admission

    Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

    Measured: 10 days

  8. Number of Ventilator-Free Days

    Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.

    Measured: 28 days

  9. Number of Therapeutic Oxygen-Free Days

    Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.

    Measured: 28 days

  10. Number of Vasopressor-Free Days

    Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

    Measured: 10 days

  11. Length of Hospital Stay

    Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.

    Measured: 90 days

  12. Disease Severity Rating

    Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

    Measured: 28 days

  13. Change in Viral Load by Nasopharyngeal Swab Day 15

    Nasopharyngeal swabs will be collected at baseline and day 15. Viral load is measured as number of viral genetic copies per mL.

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start13 Apr 2020
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04312009
Sponsor's protocol ID
SURG-2020-28675
Other IDs
INV-017069
Status last verified
Jun 2022
First submitted
13 Mar 2020
Last updated
29 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Puskarich MA, Ingraham NE, Merck LH, Driver BE, Wacker DA, Black LP, Jones AE, Fletcher CV, South AM, Murray TA, Lewandowski C, Farhat J, Benoit JL, Biros MH, Cherabuddi K, Chipman JG, Schacker TW, Guirgis FW, Voelker HT, Koopmeiners JS, Tignanelli CJ; Angiotensin Receptor Blocker Based Lung Protective Strategies for Inpatients With COVID-19 (ALPS-IP) Investigators. Efficacy of Losartan in Hospitalized Patients With COVID-19-Induced Lung Injury: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222735. doi: 10.1001/jamanetworkopen.2022.2735.

    PubMed 35294537

  • Smolander J, Bruchfeld A. [COVID-19 and kidney disease]. Lakartidningen. 2020 Jul 13;117:20110. Swedish.

    PubMed 32658300

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Losartan in people with Corona Virus Infection and Acute Respiratory Distress Syndrome, run by University of Minnesota at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04312009, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

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