Today, we will be looking into the latest research and clinical trials focused on congenital heart disease.

The following list has been carefully curated by evaluating the ongoing phase 3 trials for sepsis, targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Now, let’s go ahead and explore the list of Sepsis Clinical Trials!

Quick View Table of Sepsis Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated SepsisPHASE 350 9/22/2020 11/26/2024
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02) (VBI-S-02)PHASE 3468/6/2024 11/14/2024
Use of Midodrine in Septic Shock PatientsPHASE 32705/14/2024 11/7/2024
(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKIPHASE 367611/2/2020 6/3/2024
Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis (GRAIL^3)PHASE 35006/29/2021 1/24/2025

Phase 3 Clinical Trials:

Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis

Study Details | Source

  • Sponsor: Louisiana State University Health Sciences Center in New Orleans
  • The objective of this randomized clinical trial is to test whether administration of live attenuated MMR vaccine (measles mumps rubella; Merck) to eligible adults at highest risk for contracting COVID-19 (healthcare workers, first responders), can induce non-specific trained innate immune leukocytes that can prevent/dampen pathological inflammation and sepsis associated with COVID-19-infection, if exposed.
  • Interventions:
    • Biological: MMR vaccine
  • Primary Outcomes Measures:
    • Induction of MDSCs
      • peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline
      • Time frame - at 30 Days, 60 Days, and 1 Year

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02) (VBI-S-02)

Study Details | Source

  • Sponsor: Vivacelle Bio
  • This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
  • Interventions:
    • Drug: VBI-S
  • Primary Outcomes Measures:
    • Elevation in Average Mean Arterial Pressure
      • The primary endpoint is defined as an elevation in average mean arterial pressure by at least 10 mmHg from baseline within 3 hours of initiation of study treatment on Day 1
      • Time frame - 1 Year

Use of Midodrine in Septic Shock Patients

Study Details | Source

  • Sponsor: Mayo Clinic
  • This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.
  • Interventions:
    • Drug: Midodrine
    • Other: Standard of Care
  • Primary Outcomes Measures:
    • Time alive and without vasopressor support
      • Measured in hours
      • Time frame - 28 days

(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI

Study Details | Source

  • Sponsor: AM-Pharma
  • Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis.
  • The study has three distinct SA-AKI trial populations:
    • The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
    • A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
    • A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this population, COVID-19 should be the main cause of SA-AKI.
  • In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients.
  • There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.
  • Interventions:
    • Biological: Recombinant human alkaline phosphatase
    • Other: Placebo
  • Primary Outcomes Measures:
    • 28-day All-cause Mortality: Main Trial Population
      • To demonstrate an effect of recAP on 28 day all cause mortality
      • Time frame - 28 days
    • To demonstrate an effect of recAP on 28 day all cause mortality
      • To demonstrate an effect of recAP on 28 day all cause mortality
      • Time frame - 28 days
    • To demonstrate an effect of recAP on 28 day all cause mortality
      • To demonstrate an effect of recAP on 28 day all cause mortality
      • Time frame - 28 days

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis (GRAIL^3)

Study Details | Source

  • Sponsor: Fred Hutchinson Cancer Center
  • This is a phase 3 study designed to evaluate whether the administration of ganciclovir increases ventilator-free days in immunocompetent patients with sepsis associated acute respiratory failure. Our hypothesis is that IV ganciclovir administered early in critical illness will effectively suppress CMV reactivation in CMV seropositive adults with sepsis-associated acute respiratory failure thereby leading to improved clinical outcomes
  • Interventions:
    • Drug: IV Ganciclovir
  • Primary Outcomes Measures:
    • Respiratory-support-free days in immunocompetent patients with sepsis-associated acute respiratory failure
      • To evaluate whether administration of ganciclovir increases respiratory-support-free days in immunocompetent patients with sepsis-associated acute respiratory failure
      • Time frame - up to 28 days
Potential Guidelines That May Be Affected Include:

And there you have it - a roundup of Phase 3 clinical trials for sepsis as of January 2025. Stay tuned for our next Guidelines+ Trials Rundown! In the meantime, explore more clinical trials and sign up for alerts to stay up to date with the latest published guidelines and research.

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