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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental | Participants in this arm will receive the study drug, Losartan. |
|
| Placebo | Placebo Comparator | Participants in this arm will receive a placebo treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Losartan; 25 mg daily; oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Tignanelli, MD | University of Minnesota | Principal Investigator |
| Michael Puskarich, MD, MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States | ||
| M Health Fairview University of Minnesota Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34195577 | Result | 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. | |
| 32658300 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | Participants in this arm will receive the study drug, Losartan. Losartan: Losartan; 25 mg daily; oral administration |
| FG001 | Placebo | Participants in this arm will receive a placebo treatment. Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | Participants in this arm will receive the study drug, Losartan. Losartan: Losartan; 25 mg daily; oral administration |
| BG001 | Placebo | Participants in this arm will receive a placebo treatment. Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 15 days |
|
28 days
Events were monitored / assessed without regard to specific adverse event term, but rather by systems.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan | Participants in this arm will receive the study drug, Losartan. Losartan: Losartan; 25 mg daily; oral administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Admission | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Tignanelli | University of Minnesota | 612-626-1968 | ctignane@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2020 | Mar 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2020 | Apr 28, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D012128 | Respiratory Distress Syndrome |
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Other | Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration |
|
| 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. | 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. | 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. | 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. | 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. | 15 days |
| Change in Viral Load by Nasopharyngeal Swab at Day 9 | Viral load is measured as number of viral genetic copies per mL. | 9 days |
| Change in Viral Load by Nasopharyngeal Swab at Day 15 | Viral load is measured as number of viral genetic copies per mL. | 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. | 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. | 15 days |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Health System | Rochester | Minnesota | 55415 | United States |
| Derived |
| Smolander J, Bruchfeld A. [COVID-19 and kidney disease]. Lakartidningen. 2020 Jul 13;117:20110. Swedish. |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Only 50 patients were analyzed for this outcome measure due to loss to follow-up or refusal to complete the survey resulting in data missingness. | Posted | Mean | Standard Deviation | score on a scale | 10 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score | 10 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score | 10 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | degrees Farenheit | 10 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score | 15 days |
|
|
|
| Secondary | Change in Viral Load by Nasopharyngeal Swab at Day 9 | Viral load is measured as number of viral genetic copies per mL. | Posted | Mean | Standard Error | log10 copies/mL | 9 days |
|
|
|
| Secondary | Change in Viral Load by Nasopharyngeal Swab at Day 15 | Viral load is measured as number of viral genetic copies per mL. | Posted | Mean | Standard Error | log10 copies/mL | 15 days |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 15 days |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 15 days |
|
|
|
| 0 |
| 58 |
| 3 |
| 58 |
| 43 |
| 58 |
| EG001 | Placebo | Participants in this arm will receive a placebo treatment. Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration | 0 | 59 | 1 | 59 | 56 | 59 |
| Constitutional | Social circumstances | Non-systematic Assessment |
|
| Ear, Nose, and Throat | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Neurologic | Nervous system disorders | Non-systematic Assessment |
|
| Renal | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D007239 |
| Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |