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

2 1

What is this study about?

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.

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 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 randomization

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

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Koranyi National Institute For Pulmonology Budapest Hungary
Groupe Hospitalier Du Sud Ile De France Melun France

Other Sites

Site Name City Country Status
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Saarland University Hospital Homburg Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Tokuda Hospital Sofia Bulgaria
Cjvliq Hpoetyisbag Duqegvqkwwzda Vitmat La Roche sur Yon France
Dinbiipfnlifdgeejrbdcfa cptjqz “bsppnnytrisonay Ebck Sofia Bulgaria
Hyzykkaj Cvppnx Dd Blnrezhfb Barcelona Spain
Cttcqna Uacqejirtkumennprymz Bseojy Kts Berlin Germany
Synrtymry Rqomrcg Uokhqaoqtp Mqkkakz Cpmyoa Nijmegen The Netherlands
Fshwjxla Nlnpaaodu Kaxsywahb Vdquckdoo Prague Czechia
Hpibddny Czvqvaz Sou Cdrbho Madrid Spain
Aiathnp Ozqlimrvbzv Umkmawmmbebac Fkjlgsrd Ic Dh Ntylfl Naples Italy
Sysur Sdbf Jirk Dx Riws Reus Spain
Kwqaolfa dar Uwtgdbvkhcci Mrkwufky Adi Munich Germany
Vrcqzxjvz Fervhkcn Nubutbqgm V Porvg Prague Czechia
Cmvbqe hojgqrbkcjj uzfppfqlisbew dn Luplb Liege Belgium
Cllfnw Hyoskwbxyug Lcoo Shz Pierre Benite France
Hsnftipg Uwjamswiaiuvu 1a Dv Ozmtxyf Madrid Spain
Uprumyrauz Dntin Stlak Dj Baawdnt Brescia Italy
Maflmrm Spnjzpos Tkgcqv Enschede The Netherlands
Hdxzaxqz Uwpoploftuumwj Srxnlatnie &hnstso Hsnvguw du Hcqssasalyz STRASBOURG, Alsace France
Zqdplxbejs Gznvbqrz Vxbnln Stndhvahb Ede The Netherlands
Fbmxh Vwjkmpxtt Spfjl Gggkjxj Eqztyqqk Okgetw Kizgcf Szekesfehervar Hungary
Uhrznqbuaa Meubksgsqbfz Hvpvhshz Fpu Arseps Txeqmdibx Syahk Ggrlub Eso Plovdiv Bulgaria
Pdud Tobcq Hrgyaeym Uzvbxxfxywzh Sabadell Spain
Uiyrcsvqza Tbcdekni Hskticwr Mmrkkgdtvdcm Szombathely Hungary
Sruwoobl Cwywzs Jlehtmdk Dx Unmqqgw Pqjx Bhnkjfk Timisoara Romania
Vzimynnt Vhhgrozcb Cnoslbnt Fdqivy Kcyfrk Veszprem Hungary
Htqeug Charleroi Belgium
Scyiice Kkgfdruoniefkefccqolf Siofok Hungary
Kewwngl nhijetatd Lhnkmyt ahat Liberec Czechia
Stqlbnoxalwudmiusbhiux Vrmclpuqr Oirgjonmaary Nyiregyhaza Hungary
Fomvirlf Nvnjyhgzo U Sh Arnu V Bddb Brno-Stred Czechia
Gslcwacyxgsswtkqb Vdlwhwxkq Pxxw Avnxko Ezpequuw Owfdqn Kvgzio Gyor Hungary
Mzttxfwm Mmiwvip Axxrrju Pleven Bulgaria
Ghldc Hjulvdbbg Zutphen The Netherlands
Sfydhpgv Cdxwaq Jciisrnc Misbu Targu Mures Romania
Jlfyiy Bbyml Zuahgswciu Swisxktdu S-Hertogenbosch The Netherlands
Eqrxt Ujlhgglabt Ewbfapakn Hgmreqmb Bucharest Romania
Hovhilhi Uqxvfegzyvalq Dl Gfujjr Getafe Spain
Hmqughap Uamnvylzxyie Jddw Xtqvz Di Txlqmwwmp Tarragona Spain
Sclkl Dhfchw Gkxpkcsgudwxnhij Kmqxpw Kisvarda Hungary
Cjficeyh Srhoqphpttyp Oljlznhdn (jeyuw Ottignies Belgium
Ctb Kctskmo Byaxdey Le Kremlin-Bicetre France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2024
Bulgaria Bulgaria
Recruiting
01.11.2024
Czechia Czechia
Recruiting
01.11.2024
France France
Recruiting
01.11.2024
Germany Germany
Recruiting
01.11.2024
Hungary Hungary
Recruiting
01.11.2024
Italy Italy
Recruiting
01.11.2024
Romania Romania
Recruiting
01.11.2024
Spain Spain
Recruiting
01.11.2024
The Netherlands The Netherlands
Recruiting
01.11.2024

Trial locations

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.

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 ID:
2023-510109-16-00
Protocol code:
BTI-203
NCT ID:
NCT05947955
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of inhaled aprotinin for treatment of moderate to severe acute respiratory distress syndrome

    Recruiting

    3 1
    Investigated Drugs:
    Spain
  • Study on Anticoagulation Strategies with Heparin, Enoxaparin, and Argatroban for Patients with Respiratory or Circulatory Failure on ECMO Support

    Recruiting

    3 1 1 1
    Austria