Philippe R. Bauer, M.D., Ph.D.

Closed for Enrollment

• A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A Rochester, Minn.

  The purpose of this study is to assess the effectiveness and safety of giving anti-influenza immune plasma, as an addition to standard of care antivirals, to patients hospitalized with severe influenza A infection.

• A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002) Rochester, Minn.

  This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.

• An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19 Rochester, Minn.

  The purpose of this study is to evaluate the safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.

• INternational Observational Study to Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients (INTUBE) Rochester, Minn.

  Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill patients and major severe complications such as severe hypoxia, cardiovascular collapse and cardiac arrest are common. Despite the high risk of the procedure, different interventions lack high-quality evidence and the investigators hypothesize that a heterogeneous practice among different centres and geographical areas may be found. The investigators designed a large international observational study aiming at prospectively collecting data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients. Investigators will collect data on all consecutive in-hospital (intensive care unit, emergency department and wards) ETIs performed in adult critically patients.

• Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients Rochester, Minn., Jacksonville, Fla.

  The purpose of this study is to compare the time to recovery of CPI-006 plus Standard of Care (SOC) versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection.