Trial Outcomes & Findings for Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection (NCT NCT04340557)

NCT ID: NCT04340557

Last Updated: 2021-05-26

Results Overview

Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
• Results posted on: 2021-05-26

Participant Flow

Participant milestones

Measure	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.	Standard of Care Patient will receive the hospital Standard of Care for their condition
Overall Study STARTED	16	15
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	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.	Standard of Care Patient will receive the hospital Standard of Care for their condition
Overall Study Transferred to ICU and/or death	1	2

Baseline Characteristics

Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection

Baseline characteristics by cohort

Measure	Group A (Study Drug+SOC) n=16 Participants 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.	Group B (SOC) n=15 Participants Standard of Care	Total n=31 Participants Total of all reporting groups
Age, Continuous	54 years n=93 Participants	53 years n=4 Participants	53 years n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Race/Ethnicity, Customized White	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Black/African America	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Days from Hospital Admission to Enrollment	2 days n=93 Participants	2 days n=4 Participants	2 days n=27 Participants
Charlson Comorbidity Index	2.06 scores on a scale n=93 Participants	1.87 scores on a scale n=4 Participants	1.97 scores on a scale n=27 Participants
Comorbidities Diabetes mellitus	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Comorbidities Hypertension	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Comorbidities Obesity (BMI >/= 30 kg/m^2)	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Comorbidities Tobacco Use	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Comorbidities Cardiovascular Disease	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Receipt of Concomitant SARS-CoV-2 Medications Remdesivir	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Receipt of Concomitant SARS-CoV-2 Medications Glucocorticoids > 2 doses	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Receipt of Concomitant SARS-CoV-2 Medications Azithromycin	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Receipt of Concomitant SARS-CoV-2 Medications Hydroxychloroquine	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Receipt of Concomitant SARS-CoV-2 Medications Convalescent Plasma	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Receipt of Concomitant SARS-CoV-2 Medications Anti-thrombotics	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Group A (Study Drug+SOC) n=16 Participants 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.	Group B (SOC) n=15 Participants Standard of Care
Mechanical Ventilation	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Group A (Study Drug+SOC) n=16 Participants 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.	Group B (SOC) n=15 Participants Standard of Care
ICU Transfer	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Group A (Study Drug+SOC) n=16 Participants 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.	Group B (SOC) n=15 Participants Standard of Care
Oxygen Therapy	10,469 liters Interval 0.0 to	82,734 liters Interval 0.0 to

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Group A (Study Drug+SOC) n=16 Participants 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.	Group B (SOC) n=15 Participants Standard of Care
Length of Hospital Stay	9 days Interval 3.0 to 30.0	10 days Interval 3.0 to 34.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Group A (Study Drug+SOC) n=16 Participants 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.	Group B (SOC) n=15 Participants Standard of Care
In Hospital Mortality	1 Participants	1 Participants

Adverse Events

Group A (Study Drug+SOC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Group B (SOC)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A (Study Drug+SOC) n=16 participants at risk 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.	Group B (SOC) n=15 participants at risk Standard of Care
Vascular disorders Hypotension (SBP<100)	18.8% 3/16 • Number of events 3 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.	26.7% 4/15 • Number of events 4 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.
General disorders Body aches	6.2% 1/16 • Number of events 1 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.	6.7% 1/15 • Number of events 1 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.
General disorders Cough	0.00% 0/16 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.	13.3% 2/15 • Number of events 2 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.
General disorders Headache	0.00% 0/16 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.	13.3% 2/15 • Number of events 2 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.
General disorders Transaminitis	6.2% 1/16 • Number of events 1 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.	6.7% 1/15 • Number of events 1 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.
General disorders Malnutrition	0.00% 0/16 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.	13.3% 2/15 • Number of events 2 • From enrollment into the study until hospital discharge or death, assessed up to 45 days.

Additional Information

Matthew Geriak, PharmD

Sharp HealthCare

Phone: 858-939-3717

Email: matthew.geriak@sharp.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place