Study on FX06 for Improving Acute Respiratory Distress Syndrome in Patients

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called FX06 on patients with Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition that affects the lungs, making it difficult for patients to breathe on their own. The treatment being tested, FX06, is a solution for injection that contains a substance known as glutenin. The study will compare the effects of FX06 with a placebo to see if it can help improve the severity of the disease.

The main goal of the study is to determine if FX06 can reduce the time it takes for patients to start breathing without assistance. Participants in the study will receive either FX06 or a placebo, and their progress will be monitored over a period of 28 days. The study will look at various factors, including how the disease progresses or improves, lung function, and overall survival. Other aspects such as inflammation levels, hospital stay duration, and safety will also be assessed.

Throughout the study, participants will undergo regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable insights into whether FX06 can be an effective treatment for ARDS, potentially leading to better outcomes for patients with this challenging condition.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin Definition.

The patient must be at least 18 years old and provide written informed consent, either personally or through a legal representative.

Randomization into the study occurs within 48 hours of the ARDS diagnosis.

2 treatment administration

The patient receives either the investigational drug FX06 or a placebo.

FX06 is administered as a solution for injection through an intravenous injection.

The treatment aims to improve the time to initial unassisted breathing (UAB) until day 28.

3 monitoring and assessments

Throughout the study, the patient’s lung function is assessed at various time points: baseline, day 3, day 6, day 10, and day 28.

Systemic inflammation markers such as troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin, and IL-6 are monitored.

Other assessments include capillary refill time, duration of hospital and ICU stay, and survival/mortality rates.

4 data analysis

Data collected from the study is analyzed to compare disease progression and improvement between the FX06 and placebo groups.

Subgroup analyses are conducted based on factors such as concomitant medication, age, sex, and the cause of ARDS.

Safety parameters are evaluated to ensure the safety of the treatment.

5 study conclusion

The study is estimated to conclude by December 31, 2025.

The primary objective is to demonstrate a difference in the time to initial unassisted breathing in patients receiving FX06 compared to those receiving placebo.

Who Can Join the Study?

Patients must be hospitalized with mild to moderate Acute Respiratory Distress Syndrome (ARDS). This is a condition where the lungs cannot provide enough oxygen to the body’s organs.
Patients must be at least 18 years old.
Patients must be randomized, which means assigned to a treatment group by chance, within 48 hours of being diagnosed with ARDS.
Patients or their legal representatives must provide written informed consent before any study procedures begin. This means they agree to participate after understanding the study details.
Patients or their legal representatives must be able to understand what the study involves and agree to participate by signing a consent form.

Who Cannot Join the Study?

Patients who are not experiencing Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition where the lungs can’t provide enough oxygen to the body’s organs.
Patients who are younger than 18 years old or older than 65 years old.
Patients who are not able to breathe on their own without assistance.
Patients who are part of a vulnerable population, which means they might have additional health or social challenges.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Hopital Beaujon	Clichy	France
Fundeni Clinical Institute	Bucharest	Romania
Gaytvg Uplqjmwajp Ffxbneeop	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	06.12.2022
Germany	Not recruiting	06.12.2022
Lithuania	Not recruiting	06.12.2022
Romania	Not recruiting	06.12.2022
Spain	Not recruiting	06.12.2022

Trial locations

FX06 is a medication being studied for its potential to improve the condition of patients with Acute Respiratory Distress Syndrome (ARDS). The main goal of the trial is to see if FX06 can help patients start breathing on their own without assistance sooner than those who do not receive the medication. The trial will monitor patients up to 28 days to compare the effectiveness of FX06 in achieving this outcome.

Investigated diseases:

Acute respiratory distress syndrome

Acute Respiratory Distress Syndrome (ARDS) – 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. As a result, organs may not get the oxygen they need to function properly. The condition typically develops quickly, often within a few hours to a few days after the initial injury or infection. Common causes include pneumonia, sepsis, trauma, and inhalation of harmful substances. ARDS can lead to rapid breathing, shortness of breath, and a feeling of suffocation.

Trial ID:

2024-519104-27-00

Protocol code:

TMP-2204-2021-47

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on FX06 for Improving Acute Respiratory Distress Syndrome in Patients

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