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| ID | Type | Description | Link |
|---|---|---|---|
| 2003902 | Other Identifier | Sharp HealthCare Institutional Review Board (SHC IRB) |
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The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization ratio will be 1:1. The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Study drug+SOC) | Experimental | Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate. |
|
| Group B (SOC) | No Intervention | Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Ventilation | Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Transfer | Number of subjects transferred from non-ICU bed to an ICU bed | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
| Oxygen Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of hospital stay from admission to discharge | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
| In Hospital Mortality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Geriak, PharmD | Sharp HealthCare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Grossmont Hospital | La Mesa | California | 91942 | United States | ||
| Sharp Chula Vista Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33977506 | Derived | Geriak M, Haddad F, Kullar R, Greenwood KL, Habib M, Habib C, Willms D, Sakoulas G. Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia. Infect Dis Ther. 2021 Sep;10(3):1323-1330. doi: 10.1007/s40121-021-00453-3. Epub 2021 May 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan + Standard of Care | Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate. Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. |
| FG001 | Standard of Care | Patient will receive the hospital Standard of Care for their condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Study Drug+SOC) | Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate. Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mechanical Ventilation | Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure | Posted | Count of Participants | Participants | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
From enrollment into the study until hospital discharge or death, assessed up to 45 days.
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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 | Group A (Study Drug+SOC) | Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate. Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension (SBP<100) | Vascular disorders | Systematic Assessment |
The generalizability is limited by small size of the study population, unblinded design, and all the subjects being screened from three hospitals in close proximity in one geographic area in Southern California.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Geriak, PharmD | Sharp HealthCare | 858-939-3717 | matthew.geriak@sharp.com |
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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 20, 2020 | May 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
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|
|
Mean number of liters of oxygen consumed
| from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
Number of subjects who expired while hospitalized
| from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
| San Diego |
| California |
| 91911 |
| United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| BG001 | Group B (SOC) | Standard of Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Days from Hospital Admission to Enrollment | Median | Full Range | days |
|
| Charlson Comorbidity Index | The revised Charlson Comorbidity Index is a weighted index to predict risk of death within 10 yrs for patients with specific comorbid conditions. 17 conditions were included in the revised index. Each condition was assigned from 0 to 6 and were summed to produce the score (https://www.mdcalc.com/charlson-comorbidity-index-cci) The lowest to highest possible score is 0 to 102. The higher the score indicates the higher probability of mortality. This scale was utilized to illustrate the clinical similarity between the two groups at baseline. | Mean | Full Range | scores on a scale |
|
| Comorbidities | Count of Participants | Participants |
|
| Receipt of Concomitant SARS-CoV-2 Medications | Count of Participants | Participants |
|
Standard of Care |
|
|
| Secondary | ICU Transfer | Number of subjects transferred from non-ICU bed to an ICU bed | Posted | Count of Participants | Participants | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
|
|
| Secondary | Oxygen Therapy | Mean number of liters of oxygen consumed | Posted | Mean | Full Range | liters | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
|
|
| Other Pre-specified | Length of Hospital Stay | Length of hospital stay from admission to discharge | Posted | Mean | Full Range | days | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
|
|
| Other Pre-specified | In Hospital Mortality | Number of subjects who expired while hospitalized | Posted | Count of Participants | Participants | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Group B (SOC) | Standard of Care | 1 | 15 | 0 | 15 | 5 | 15 |
| Body aches | General disorders | Systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Transaminitis | General disorders | Systematic Assessment |
|
| Malnutrition | General disorders | Systematic Assessment |
|
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| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |