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

SARS-CoV Infection Clinical Trial

Official title:

Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340557
• Other study ID #: COVID-ARB
• Secondary ID: 2003902
• Status: Completed
• Phase: Phase 4
• Start date: March 27, 2020
• Est. completion date: June 13, 2020

Study information

• Verified date: May 2021
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 13, 2020
• Est. primary completion date: June 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• 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. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.

Locations

Country	Name	City	State
United States	Sharp Grossmont Hospital	La Mesa	California
United States	Sharp Chula Vista Medical Center	San Diego	California
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	In Hospital Mortality	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
Primary	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
Secondary	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
Secondary	Oxygen Therapy	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