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=99 Participants
|
53 years
n=107 Participants
|
53 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African America
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Days from Hospital Admission to Enrollment
|
2 days
n=99 Participants
|
2 days
n=107 Participants
|
2 days
n=206 Participants
|
|
Charlson Comorbidity Index
|
2.06 scores on a scale
n=99 Participants
|
1.87 scores on a scale
n=107 Participants
|
1.97 scores on a scale
n=206 Participants
|
|
Comorbidities
Diabetes mellitus
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Comorbidities
Hypertension
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Comorbidities
Obesity (BMI >/= 30 kg/m^2)
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Comorbidities
Tobacco Use
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Comorbidities
Cardiovascular Disease
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Receipt of Concomitant SARS-CoV-2 Medications
Remdesivir
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Receipt of Concomitant SARS-CoV-2 Medications
Glucocorticoids > 2 doses
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Receipt of Concomitant SARS-CoV-2 Medications
Azithromycin
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Receipt of Concomitant SARS-CoV-2 Medications
Hydroxychloroquine
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Receipt of Concomitant SARS-CoV-2 Medications
Convalescent Plasma
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Receipt of Concomitant SARS-CoV-2 Medications
Anti-thrombotics
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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 daysNumber 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 daysNumber 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 daysMean 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 daysLength 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 daysNumber 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place