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

S

Sharp HealthCare

Status and phase

Completed
Phase 4

Conditions

SARS-CoV Infection

Treatments

Drug: Losartan

Study type

Interventional

Funder types

Other

Identifiers

NCT04340557
COVID-ARB
2003902 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Group A (Study drug+SOC)
Experimental group
Description:
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.
Treatment:
Drug: Losartan
Group B (SOC)
No Intervention group
Description:
Standard of Care

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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