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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-27

Study Completion Date

2020-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Patients With COVID19

NCT04364893

Corona Virus Infection COVID-19

UNKNOWN NA

Losartan Therapy in Pulmonary Hypertension

NCT00519870

Pulmonary Hypertension

COMPLETED PHASE3

Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?

NCT04606563

Covid19 SARS-CoV Infection

TERMINATED PHASE3

Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

NCT01277822

Hypertension

COMPLETED PHASE4

A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)

NCT06150560

Coarctation of Aorta High Blood Pressure

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Losartan

Intervention Type 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.

Group B (SOC)

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Losartan + Standard of Care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No