Skip to main content
OpenTrials
Completed

NCT Number: NCT04340557

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sharp Grossmont Hospital, La Mesa, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Losartan + Standard of Care

Primary outcomes

  1. Mechanical Ventilation

    Time frame: 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 outcomes

  1. ICU Transfer

    Time frame: 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

  2. Oxygen Therapy

    Time frame: 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 outcomes

  1. Length of Hospital Stay

    Time frame: 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

  2. In Hospital Mortality

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.