Corona Virus InfectionPhase 2NCT04311177
Losartan for Patients With COVID-19 Not 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 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection
- 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
- 117 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 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
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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 (must be have been measured within 1 month of enrollment)
- Other kidney disease that in the opinion of the investigator, would affect losartan clearance
- Patient reported dehydration and significantly decreased urine output in the past 72 hours
- Most recent systolic blood pressure prior to enrollment <110 mmHg
- Patient reported history or electronic medical record history of severe liver disease, defined as:
- Cirrhosis
- History of hepatitis B or C
- Other liver disease that in the opinion of the investigator, would affect losartan clearance
- Documented AST or ALT > 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic Health System
Rochester, Minnesota, 55415
About this study
Official title: Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization
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).
- 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; 25 mg daily; oral administration
PlaceboOther
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Participants in this arm will receive the study drug, Losartan. Receives: Drug: Losartan |
| Placebo | Placebo comparator | Participants 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.
Percentage of Participants Admitted to the Hospital
Outcome reported as the percentage of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization.
Currently, there is a pre-planned pooled analysis with a national trial network under development.
Measured: 15 days
Secondary outcomes (10)
Change in PROMIS Dyspnea Scale
The PROMIS dyspnea scale consists of 4 subscales. 3 (1. general shortness of breath, 2. intensity, and 3. Frequency) are scored from 0 (no symptoms) to 10 (most severe). The 4th subscale is scored from 0-4 in response to the question "I've been short of breath" with 0 representing none and 4 the most severe, for a total range of 0-34. Results are difference between enrollment and day 10. There are no units.
Measured: 10 days
Change in SF-12 Physical Composite Score
The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.
Measured: 10 days
Change in SF-12 Mental Composite Score
The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: 10 days
Daily Maximum Temperature
Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.
Measured: 10 days
Count of Participants With an Emergency Department or Clinic Presentation
Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.
Measured: 28 days
Disease Severity Rating Day 15
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: 15 days
Change in Viral Load by Nasopharyngeal Swab at Day 9
Viral load is measured as number of viral genetic copies per mL.
Measured: 9 days
Change in Viral Load by Nasopharyngeal Swab at Day 15
Viral load is measured as number of viral genetic copies per mL.
Measured: 15 days
Percentage of Patients Admitted to the Intensive Care Unit Within 15 Days
Outcome reported as the percent of participants in each arm who require ICU admission by day 15 following randomization.
Measured: 15 days
Need for Oxygen Therapy at 15 Days
Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start9 Apr 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Tignanelli, MD, Principal investigator, University of MinnesotaMichael Puskarich, MD, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311177
- Sponsor's protocol ID
- SURG-2020-28683
- Status last verified
- May 2022
- First submitted
- 13 Mar 2020
- Last updated
- 4 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puskarich MA, Cummins NW, Ingraham NE, Wacker DA, Reilkoff RA, Driver BE, Biros MH, Bellolio F, Chipman JG, Nelson AC, Beckman K, Langlois R, Bold T, Aliota MT, Schacker TW, Voelker HT, Murray TA, Koopmeiners JS, Tignanelli CJ. A multi-center phase II randomized clinical trial of losartan on symptomatic outpatients with COVID-19. EClinicalMedicine. 2021 Jun 17;37:100957. doi: 10.1016/j.eclinm.2021.100957. eCollection 2021 Jul.
PubMed 34195577Smolander J, Bruchfeld A. [COVID-19 and kidney disease]. Lakartidningen. 2020 Jul 13;117:20110. Swedish.
PubMed 32658300
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization
- ClinicalTrials.gov ID
- NCT04311177
- Acronym / sponsor ID
- SURG-2020-28683
- Keywords
- COVID-19, Corona Virus, SARS-COV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Posted 4 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: LosartanParticipants in this arm will receive the study drug, Losartan. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive a placebo treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: CozaarLosartan; 25 mg daily; oral administration | Drug | Losartan |
| PlaceboPlacebo (microcrystalline methylcellulose, gelatin capsule); oral administration | Other | Placebo |
Primary outcome
Percentage of Participants Admitted to the Hospital
Time frame: 15 days
Outcome reported as the percentage of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.
10 secondary outcomes
Change in PROMIS Dyspnea Scale
Time frame: 10 days
Change in SF-12 Physical Composite Score
Time frame: 10 days
Change in SF-12 Mental Composite Score
Time frame: 10 days
Daily Maximum Temperature
Time frame: 10 days
Count of Participants With an Emergency Department or Clinic Presentation
Time frame: 28 days
Disease Severity Rating Day 15
Time frame: 15 days
Change in Viral Load by Nasopharyngeal Swab at Day 9
Time frame: 9 days
Change in Viral Load by Nasopharyngeal Swab at Day 15
Time frame: 15 days
Percentage of Patients Admitted to the Intensive Care Unit Within 15 Days
Time frame: 15 days
Need for Oxygen Therapy at 15 Days
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34195577Puskarich MA, Cummins NW, Ingraham NE, Wacker DA, Reilkoff RA, Driver BE, Biros MH, Bellolio F, Chipman JG, Nelson AC, Beckman K, Langlois R, Bold T, Aliota MT, Schacker TW, Voelker HT, Murray TA, Koopmeiners JS, Tignanelli CJ. A multi-center phase II randomized clinical trial of losartan on symptomatic outpatients with COVID-19. EClinicalMedicine. 2021 Jun 17;37:100957. doi: 10.1016/j.eclinm.2021.100957. eCollection 2021 Jul.
- Derived from this study: PubMed 32658300Smolander J, Bruchfeld A. [COVID-19 and kidney disease]. Lakartidningen. 2020 Jul 13;117:20110. Swedish.
- Individual participant dataSharing planned: No
Related trials for Corona Virus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Tignanelli, MD principal investigator
University of Minnesota
Michael Puskarich, MD, MS principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
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 4 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 3 inclusion and 22 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 May 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?
Percentage of Participants Admitted to the Hospital (time frame: 15 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 NCT04311177, 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 4 May 2022.