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Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Acute Respiratory Distress Syndrome (ARDS), which can occur due to pneumonia or other infections. ARDS is a serious lung condition that makes it difficult to breathe. The study is testing a treatment called Recombinant Human Plasma Gelsolin, also known as rhu-pGSN, which is given through an intravenous infusion. This means the treatment is administered directly into the bloodstream through a vein. The trial will compare the effects of rhu-pGSN with a placebo, which is a substance with no active medication, to see if rhu-pGSN is safe and beneficial for patients with moderate-to-severe ARDS.

The purpose of the study is to evaluate how well rhu-pGSN works in combination with the standard care that patients with ARDS usually receive. Participants in the study will be randomly assigned to receive either rhu-pGSN or a placebo, along with their regular treatment. The study will monitor participants over a period of time to assess their recovery and any side effects they may experience. The main focus will be on the survival rate of participants and their need for respiratory support, such as ventilators, during the study period.

Throughout the study, researchers will collect information on how many days participants can breathe without the help of a ventilator and how long they stay in the hospital. The study will also look at the overall safety of rhu-pGSN by tracking any new or worsening health issues that occur. This research aims to provide valuable insights into whether rhu-pGSN can improve outcomes for patients suffering from ARDS due to infections like pneumonia.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. Informed consent must be obtained from the patient or their legal representative.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of moderate-to-severe acute respiratory distress syndrome (ARDS) due to pneumonia or other infections.

  3. Step 3

    Randomization

    The patient will be randomly assigned to receive either the recombinant human plasma gelsolin or a placebo (0.9% saline solution).

  4. Step 4

    Treatment administration

    The assigned treatment will be administered through an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    The patient's health will be closely monitored throughout the study. This includes tracking the number of days without the need for a ventilator, overall survival, and any side effects or adverse events.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, the patient's condition will be evaluated to assess the effectiveness and safety of the treatment.

  7. Step 7

    Final follow-up

    A final follow-up will occur to gather data on the patient's recovery and any long-term effects of the treatment.

Who can join the trial?

8 criteria

  • The patient must have an infection that led to **Acute Respiratory Distress Syndrome (ARDS)** within a week. ARDS is a serious lung condition that makes it hard to breathe. This must be confirmed by a doctor or a radiologist, and the findings should be recorded and saved.
  • The patient must have **acute hypoxemic respiratory failure** for 48 hours or less. This means they have trouble getting enough oxygen into their blood due to ARDS. They should be receiving help to breathe, such as being on a ventilator, using a mask that provides air pressure, or receiving a high flow of oxygen.
  • The patient must be **18 years or older**.
  • The patient or their legal representative must give **informed consent** to participate in the study. This means they understand the study and agree to take part.
  • There must be clear evidence of an infection that caused ARDS within the 7 days before the ARDS diagnosis, as judged by the medical team.
  • During the study and for 4 days after the last treatment, for a total of 10 days:
    • Women who can have children must agree to avoid pregnancy by using two approved birth control methods or abstaining from sex.
    • Men with partners who can become pregnant must agree to use reliable birth control methods, like a vasectomy or abstinence, or ensure their partner uses an acceptable method.
    • All participants must agree not to donate sperm or eggs.

Who cannot join the trial?

6 criteria

  • Patients who do not have a primary diagnosis of **moderate-to-severe Acute Respiratory Distress Syndrome (ARDS)** due to pneumonia or other infections cannot participate. ARDS is a serious condition where the lungs cannot provide enough oxygen to the body's organs.
  • Patients with a **P/F ratio** greater than 150 cannot participate. The P/F ratio is a measure of how well the lungs are working, specifically how much oxygen is in the blood compared to the amount of oxygen being given to the patient.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
  • Patients who do not belong to the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients, but the exact group is not detailed here.
  • Both **male and female** patients are eligible, so exclusion is not based on gender.
  • Patients who are not considered part of a **vulnerable population** cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain disabilities, but the specific group is not detailed here.
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Investigated drugs

Recombinant Human Plasma Gelsolin (rhu-pGSN) is a medication being studied for its potential to help patients with moderate-to-severe acute respiratory distress syndrome (ARDS) caused by pneumonia or other infections. It is used in addition to the standard care that patients are already receiving. The goal of using this medication is to see if it can improve the condition of patients by reducing the severity of ARDS symptoms.

What is already known about the treatment

Recombinant Human Plasma Gelsolin (rhu-pGSN) – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) caused by pneumonia or other infections. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication is to serve as an adjunctive therapy alongside standard care for ARDS. At the molecular level, rhu-pGSN works by modulating the actin cytoskeleton, which may help reduce inflammation and improve lung function. It is classified pharmacologically as a recombinant protein therapy.

Investigated diseases

Acute Respiratory Distress Syndrome (ARDS) Due to Pneumonia or other Infections – ARDS is a severe lung condition that occurs when fluid builds up in the tiny, elastic air sacs in the lungs. This fluid prevents the lungs from filling with enough air, which means less oxygen reaches the bloodstream. It often develops in people who are already critically ill or have significant injuries. The condition progresses rapidly, usually within a few hours to a few days after the initial injury or infection. As ARDS progresses, breathing becomes increasingly difficult, and the patient may require mechanical ventilation. The severity of ARDS can vary, and it is often associated with pneumonia or other infections that cause inflammation in the lungs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510109-16-00Protocol codeBTI-203Estimated enrolment600 patientsSponsorBioaegis Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).