# A Device for the Prevention and Treatment of Multiple Organ Failure in COVID-19 Patients

> **NIH NIH R44** · THERANOVA, LLC · 2020 · $398,966

## Abstract

Abstract
Multiple organ failure (MOF) is a common cause of morbidity and mortality for individuals in the intensive care
unit (ICU) including those suffering from COVID-19. Prevention of multiorgan injury and subsequent treatment
should be a focus in the ICU, and is thought to be especially important in supportive care of critically ill patients
and COVID-19 patients. In efforts to prevent and treat MOF, the gut may be a key target as it is a driver of MOF
development. Specifically, critical illness has the potential to compromise gut perfusion in many patients
(including those with embolic or shock insult), which can propel a pathological response
initiating systemic
inflammatory response syndrome (SIRS)
leading to MOF. A novel treatment may be direct peritoneal
resuscitation (DPR), which consists of circulating commercially available peritoneal dialysis solution throughout
the peritoneal cavity. DPR improves tissue perfusion and reduces cellular ischemia. In turn, DPR has been
extensively proven to attenuate SIRS, increase blood flow in end-organs with corresponding decreased injury
and improve survival in preclinical small animal models of hemorrhagic shock (HS). Further, significant clinical
benefits of DPR have been demonstrated in 1) improved recovery of patients requiring surgical management of
abdominal catastrophe (trauma, sepsis and necrotizing enterocolitis) and 2) significantly increased numbers of
organs transplanted from brain dead, heart beating donors. However, the risk of injury-related complications
during peritoneal access is a substantial roadblock to the clinical utility of DPR, especially for unstable, critically
ill patients, who require peritoneal catheter placement to be quick, safe and conducted at the bedside. To bring
the benefits of DPR to the ICU, TheraNova has developed the Multi-Organ Failure Treatment (MOFT). MOFT
has two functions: 1) safe, quick bedside access through the use of a proprietary Peritoneal Access System
(PAS), and 2) autonomous DPR through the use of a Lavage Controller (LC). In our preliminary work, we have
demonstrated 1) attenuated risk of tissue injury, 2) timely peritoneal access, 3) evidence-based insertion
guidance, and 4) consistent, autonomous peritoneal lavage. The goal of this revision application is to validate
MOFT in a clinically relevant and reproducible animal model before translation to clinical use. First, we will
enhance device utility by optimizing the MOFT PAS controller to enable three modalities of evidence-based
guidance within a centralized hub (Aim 1). We will then conduct a randomized, controlled study with an HS swine
model to demonstrate safe and effective peritoneal access (Aim 2.1) and DPR treatment for the prevention of
gut-derived systemic inflammation and organ injury (Aim 2.2). Successful completion of this proposed effort will
provide sufficient evidence to file for an Investigational Device Exemption with the FDA. We will then initiate pilot
clinical studies in ...

## Key facts

- **NIH application ID:** 10165404
- **Project number:** 3R44AG058272-03S1
- **Recipient organization:** THERANOVA, LLC
- **Principal Investigator:** Daniel Rogers Burnett
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $398,966
- **Award type:** 3
- **Project period:** 2017-12-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10165404

## Citation

> US National Institutes of Health, RePORTER application 10165404, A Device for the Prevention and Treatment of Multiple Organ Failure in COVID-19 Patients (3R44AG058272-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10165404. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*