Phase 2 study to evaluate efficacy & safety of rhu-pGSN with standard of care for ARDS

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Recombinant Human Plasma Gelsolin With Standard Of Care for Moderate-to-Severe ARDS Due to Pneumonia or Other Infections

• IRAS ID

  1009841

• Contact name

  Susan Levinson

• Contact email

  slevinson@bioaegistx.com

• Sponsor organisation

  BioAegis Therapeutics, Inc.

• Eudract number

  2023-510109-16

• Clinicaltrials.gov Identifier

  NCT05947955

• Research summary

  This is a clinical trial that studies a potential new treatment called recombinant human plasma gelsolin. Gelsolin is being studied in patients who have developed acute respiratory distress syndrome (ARDS). This is a condition that occurs when there is a severe damage to the lungs that prevents oxygen uptake into the blood and can be life threatening. The body's uncontrolled reaction to an infection is one of the causes of ARDS.
  Each patient who has been diagnosed with an infection that required admission to hospital, or occurred in hospital, will be checked to see if he or she can be part of this study. Patients/legal representative will sign an Informed Consent Form before any study screening procedures are done to see if the patient can be part of the study.
  If the participant has all of the requirements and none of the reasons that they cannot be part of the study, then they will be given either gelsolin or placebo (that is intravenous salt water and looks exactly like gelsolin). Placebos are used to make sure the results of a study cannot be unfairly influenced by anyone. Half of the patients who take part in this study will receive gelsolin and half will receive placebo. This is done to make the groups similar in size, which makes comparing the groups fairer. The choice of getting gelsolin or placebo is like flipping a coin and is made by a computer.
  A total of six doses will be given. Each dose must be given about 24 hours after the previous dose.
  The gelsolin or placebo will be given in addition to all of the standard treatment that patients already receive for ARDS.
  Participants are followed for 28 days to see the effect of gelsolin on improving survival, daily use of oxygen and mechanical ventilation and hospital resources

• REC name

  Wales REC 5

• REC reference

  24/WA/0312

• Date of REC Opinion

  12 Nov 2024

• REC opinion

  Further Information Favourable Opinion