SARS-CoV Infection
Conditions
Keywords
Coronavirus, Angiotensin receptor blocker, SARS-CoV-2, COVID-19
Brief summary
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.
Detailed description
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.
Interventions
DRUGLosartan
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.
Sponsors
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed COVID-19 positive test result * Mild to moderate respiratory symptoms of COVID-19. * Systolic blood pressure ≥ 105 mmHg. * Screen within 3 days of a positive COVID-19 test. * Age ≥18 years old. * Access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls. * Able to read/write/speak English or Spanish fluently. * Subjects must have the capacity to provide consent or an appropriate LAR to provide informed consent. * Negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.
Exclusion criteria
* Severe allergy to any ARB or ACE-inhibitor, including angioedema * In the intensive care unit at screening. * Home meds include any kind of ACE inhibitor or ARB * Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm) * Hyperkalemia \>5.0 mmol/L at baseline or any time during treatment in the study treatment arm * Creatinine Clearance \< 30 ml/min at baseline or any time during treatment in the study treatment arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation | 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 requiring transfer into ICU for mechanical ventilation due to respiratory failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Transfer | 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 transferred from non-ICU bed to an ICU bed |
| Oxygen Therapy | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | Mean number of liters of oxygen consumed |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | Length of hospital stay from admission to discharge |
| In Hospital Mortality | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Group B (SOC) Standard of Care | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Transferred to ICU and/or death | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Group A (Study Drug+SOC) | Group B (SOC) |
|---|---|---|---|
| Age, Continuous | 53 years | 54 years | 53 years |
| Charlson Comorbidity Index | 1.97 scores on a scale | 2.06 scores on a scale | 1.87 scores on a scale |
| Comorbidities Cardiovascular Disease | 1 Participants | 1 Participants | 0 Participants |
| Comorbidities Diabetes mellitus | 8 Participants | 3 Participants | 5 Participants |
| Comorbidities Hypertension | 12 Participants | 7 Participants | 5 Participants |
| Comorbidities Obesity (BMI >/= 30 kg/m^2) | 13 Participants | 8 Participants | 5 Participants |
| Comorbidities Tobacco Use | 6 Participants | 4 Participants | 2 Participants |
| Days from Hospital Admission to Enrollment | 2 days | 2 days | 2 days |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African America | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 25 Participants | 12 Participants | 13 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 1 Participants | 2 Participants |
| Receipt of Concomitant SARS-CoV-2 Medications Anti-thrombotics | 0 Participants | 0 Participants | 0 Participants |
| Receipt of Concomitant SARS-CoV-2 Medications Azithromycin | 5 Participants | 2 Participants | 3 Participants |
| Receipt of Concomitant SARS-CoV-2 Medications Convalescent Plasma | 2 Participants | 1 Participants | 1 Participants |
| Receipt of Concomitant SARS-CoV-2 Medications Glucocorticoids > 2 doses | 7 Participants | 2 Participants | 5 Participants |
| Receipt of Concomitant SARS-CoV-2 Medications Hydroxychloroquine | 3 Participants | 2 Participants | 1 Participants |
| Receipt of Concomitant SARS-CoV-2 Medications Remdesivir | 9 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 19 Participants | 10 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 1 / 15 |
| other Total, other adverse events | 3 / 16 | 5 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
Mechanical Ventilation
Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (Study Drug+SOC) | Mechanical Ventilation | 1 Participants |
| Group B (SOC) | Mechanical Ventilation | 1 Participants |
Secondary
ICU Transfer
Number of subjects transferred from non-ICU bed to an ICU bed
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (Study Drug+SOC) | ICU Transfer | 1 Participants |
| Group B (SOC) | ICU Transfer | 2 Participants |
Secondary
Oxygen Therapy
Mean number of liters of oxygen consumed
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group A (Study Drug+SOC) | Oxygen Therapy | 10,469 liters |
| Group B (SOC) | Oxygen Therapy | 82,734 liters |
Other Pre-specified
In Hospital Mortality
Number of subjects who expired while hospitalized
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (Study Drug+SOC) | In Hospital Mortality | 1 Participants |
| Group B (SOC) | In Hospital Mortality | 1 Participants |
Other Pre-specified
Length of Hospital Stay
Length of hospital stay from admission to discharge
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group A (Study Drug+SOC) | Length of Hospital Stay | 9 days |
| Group B (SOC) | Length of Hospital Stay | 10 days |