A Randomized, Phase 2 Clinical Trial of HIF Activator Vadadustat for Prevention or Treatment of ARDS in Hospitalized COVID-19 Patients
Abstract
COVID-19 is a recently emerged respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). During the past months, COVID-19 has become a pandemic with currently over four million patients worldwide, and over 1,400,000 documented infections in the US alone and high daily death rates. The main purpose of this application is to define novel pharmacologic approaches to prevent or treat acute respiratory distress syndrome (ARDS) in COVID-19 patients. As such, we will assess how well an oral drug, Vadadustat, given once a day for 14 days works for the prevention and treatment of ARDS in patients hospitalized with COVID-19 infection. This trial will investigate the superiority of Vadadustrat to placebo for the prevention and treatment of ARDS among COVID-19 patients. Specifically, we hypothesize that Vadadustat will decrease inflammation to the lungs, consequently reducing the necessity of mechanical ventilation due to COVID-19 infection. Preliminary data show that Vadadustat has demonstrated an outstanding safety record following completion of Phase 1, Phase 2, and ongoing Phase 3 trials in patients to correct renal anemia. Following screening, consented patients will be randomized to the drug under investigation (placebo vs. Vadadustat). In the first aim of the proposed study, we will assess safety and efficacy of both treatments over 14 days. In the second and third aims of the study, proteins involved in COVID-19-induced inflammation will be determined in blood previously collected in control conditions (prior to drug administration), at days 7 and 14. Data will be collected and analyzed accordingly. In summary, finding novel, long-lasting approaches to prevent or treat SARS-CoV-2-associated ARDS is our primary objective. The overall outcome of the proposed Phase 2 multi-center randomized, double-blind, placebo-controlled clinical trial will be critical to the understanding of Vadadustat in lowering the risks of organ injury in COVID-19 hospitalized patients and how this knowledge will aid in the development of safe and effective medical countermeasures. Further, it will heighten national security by providing populations at risk of COVID-19 exposure (soldiers, factory workers, and civilian bystanders) with Vadadustat, a drug that would prevent and/or reduce the progression of ARDS. Because we have assembled a team of medical doctors and scientists with unique expertise in emergency medicine, infectious diseases, trauma-anesthesiology, and experimental biology, important information will be discovered that will lead to prevent or treat patients suffering from COVID-19-induced ARDS.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110032
Entities
People
- Holger K. Eltzschig
Organizations
- United States Army
- University of Texas Health Science Center at Houston