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Kidney Week

Abstract: PO0863

Design of PREVENT: A Phase 2 Study of the Effect of RBT-9 on Progression of COVID-19 Infection in High-Risk Individuals, Including Those with Advanced CKD

Session Information

Category: Coronavirus (COVID-19)

  • 000 Coronavirus (COVID-19)

Authors

  • Ruiz, Stacey, Renibus Therapeutics, Southlake, Texas, United States
  • Lavin, Philip T., Boston Biostatistics Research Foundation, Framingham, Massachusetts, United States
  • Keyser, Donald Jeffrey, Renibus Therapeutics, Southlake, Texas, United States
  • Guillem, Alvaro F., Renibus Therapeutics, Southlake, Texas, United States
  • Zager, Richard A., Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
  • Singh, Bhupinder, University of California Irvine, University of California Irvine, Irvine, CA, US, Department of Medicine, Irvine, California, United States
Background

Coronavirus 2019 (COVID-19) has infected millions of people worldwide, with the US reporting the most deaths. Many individuals are at high risk of disease progression, which may result in multi-organ failure and death. Risk factors include advanced age, cardiovascular disease (CVD), and chronic kidney disease (CKD). In addition, more than 40% of hospitalized patients develop acute kidney injury (AKI), with 20% of those requiring dialysis. Several therapeutic agents are in development, but patients with advanced CKD or those requiring immunosuppressive therapy are frequently excluded from participation in clinical trials.

RBT-9, a proprietary formulation of stannous protoporphyrin, has organ protective effects, as demonstrated in animal models of kidney, liver, and lung injury. RBT-9 also has antiviral effects, as demonstrated in several enveloped viruses, including influenza, HCV, dengue, and yellow fever. A Phase 2, randomized, placebo-controlled study was designed to evaluate the effect of RBT-9 on progression of COVID-19 infection in high-risk individuals.

Methods

This study will enroll up to 252 subjects with documented SARS-CoV-2 infection who are at risk of progression based on age (≥70 years) or comorbidities, including CKD (all stages, not on dialysis), CVD, chronic lung disease, diabetes mellitus, obesity, and mild hypoxemia. Subjects will be randomized 2:1 to receive a single dose of RBT-9 or placebo and will be followed for 56 days.

Results

Study Objectives
The primary objective is to evaluate the effect of RBT-9 versus placebo on clinical status measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale at Day 28. Secondary objectives include time to first occurrence of death from any cause or new/worsened organ dysfunction, survival, AKI incidence, new or worsening heart failure, hospitalization status and duration, ICU status, days on ventilator, vasopressor utilization or ventricular arrythmias.

Conclusion

The organ protective and antiviral effects of RBT-9 warrant conduct of this clinical study, which is aimed at preventing progression to severe COVID-19 and organ failure. The first patient is expected to be enrolled in June 2020.

Funding

  • Commercial Support