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

NCT04340557 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: COVID-ARB2003902
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

SARS-CoV Infection

Keywords

Coronavirus; Angiotensin receptor blocker; SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ICU Transfer

  from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

• Oxygen Therapy

  from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Other Outcomes (2)

• Length of Hospital Stay

  from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

• In Hospital Mortality

  from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Study Arms (2)

Group A (Study drug+SOC)

EXPERIMENTAL

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.

Drug: Losartan

Group B (SOC)

NO INTERVENTION

Standard of Care

Interventions

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.

Also known as: Losartan + Standard of Care

Group A (Study drug+SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (3)

Sharp Grossmont Hospital

La Mesa, California, 91942, United States

Location

Sharp Chula Vista Medical Center

San Diego, California, 91911, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Related Publications (1)

• Geriak M, Haddad F, Kullar R, Greenwood KL, Habib M, Habib C, Willms D, Sakoulas G. Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia. Infect Dis Ther. 2021 Sep;10(3):1323-1330. doi: 10.1007/s40121-021-00453-3. Epub 2021 May 11.

  PMID: 33977506 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Coronavirus Infections; COVID-19

Interventions

Losartan; Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The generalizability is limited by small size of the study population, unblinded design, and all the subjects being screened from three hospitals in close proximity in one geographic area in Southern California.

Results Point of Contact

• Title: Matthew Geriak, PharmD
• Organization: Sharp HealthCare

matthew.geriak@sharp.com

858-939-3717

Study Officials

• Matthew Geriak, PharmD

  Sharp HealthCare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigational Pharmacist

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

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: March 27, 2020
• Primary Completion: June 13, 2020
• Study Completion: June 13, 2020
• Last Updated: May 26, 2021
• Results First Posted: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)