A study testing trimodulin in hospitalized adult patients with community-acquired pneumonia including COVID-19 pneumonia

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What is this study about?

This study involves patients with community-acquired pneumonia or COVID-19 pneumonia who need to be in the hospital and require oxygen support. Community-acquired pneumonia is a lung infection that people get outside of hospitals or healthcare facilities, while COVID-19 pneumonia is a lung infection caused by the coronavirus. The treatment being tested is called trimodulin, also known by its code name BT588, which is a solution made from human blood that contains three types of antibodies called IgM, IgA, and IgG. These antibodies are proteins that help the immune system fight infections. Some patients will receive trimodulin while others will receive placebo, both given through a vein along with the standard care that all patients normally receive for their lung infection.

The purpose of this study is to find out if trimodulin is effective and safe when added to standard care for treating hospitalized adult patients with community-acquired pneumonia or COVID-19 pneumonia. The study will look at whether patients who receive trimodulin do better than those who receive placebo by measuring how many patients get worse or die during the study period. Patients in the study will receive the treatment through an infusion into a vein over five days.

During the study, doctors will monitor patients for up to 91 days to see how they respond to treatment. They will check if patients need more intensive breathing support or if their condition improves, stays the same, or gets worse. The study will also measure various blood markers related to inflammation, immune system function, and blood clotting to understand how the treatment works in the body. Safety will be carefully watched by recording any unwanted effects that occur during and after the treatment period.

1 Treatment initiation

Your treatment with the study medication must begin within 7 days after your first hospital admission for pneumonia.

At the start of treatment, you will be receiving oxygen support through a mask or nasal prongs with more than 2 liters per minute, or through non-invasive breathing support, or through high-flow oxygen.

2 Study medication administration

You will receive either trimodulin (a solution containing human antibodies: IgM, IgA, and IgG) or placebo (a solution containing 1% human albumin, which is a protein found in blood).

The medication will be given through intravenous infusion, which means it will be delivered directly into your vein.

The treatment will be provided in addition to your standard care for pneumonia.

3 Monitoring during treatment period

Your medical condition will be regularly assessed during the treatment.

Blood samples will be taken to measure levels of IgM, IgA, and IgG (types of antibodies in your blood) at baseline, during treatment, and after treatment.

Additional blood samples will be collected to check for factors related to blood clotting, inflammation markers, complement factors (proteins that help fight infections), biomarkers, and antibodies against SARS-CoV-2 virus and pneumonia bacteria.

Your oxygen levels and breathing status will be monitored throughout the study.

4 Assessment period up to day 29

Your clinical status will be evaluated regularly from day 1 through day 29.

The assessment will track whether your condition improves, stays the same, or worsens.

Your recovery will be measured using a scoring system, with the goal of reaching a score of 2 or lower.

Any side effects or adverse events will be recorded during this period.

5 28-day evaluation

On day 29 (with a possible window of plus or minus 3 days), a comprehensive evaluation will be performed.

This evaluation will determine your overall clinical status and whether you have recovered to a score of 2 or lower.

All adverse events, including their severity, relationship to the study medication, and outcomes, will be documented.

6 Extended follow-up to day 91

Your health status will continue to be monitored until day 91 (90 days after treatment start).

This extended follow-up period allows for the assessment of longer-term outcomes and any delayed effects of the treatment.

Who Can Join the Study?

You or your legally acceptable representative (a person legally allowed to make decisions on your behalf) must provide written permission to participate in the study, following all local legal rules.
You must be admitted to the hospital.
You must be an adult, which means you are 18 years of age or older.
You can be of any gender.
You must have been diagnosed with community-acquired pneumonia (a lung infection you got outside of a hospital) or COVID-19 pneumonia (lung infection caused by the coronavirus) either before entering the hospital or within 48 hours after being admitted.
You must have imaging results, such as chest X-rays or scans, showing new areas of infection in one or more sections of your lungs that match either community-acquired pneumonia or COVID-19 pneumonia.
You must be receiving oxygen support at the time treatment starts, which can be through low-flow oxygen (oxygen given through a mask or nose tubes with more than 2 liters per minute), non-invasive ventilation (breathing support without tubes inserted into your airway), or high-flow oxygen (oxygen given at higher rates).
Within 24 hours before starting the study treatment, you must meet at least one of these breathing-related conditions: your oxygen saturation (the amount of oxygen in your blood measured by a device on your finger) is 94 percent or lower when breathing room air without having a pre-existing chronic lung disease, or your PaO2/FiO2 ratio (a measurement comparing oxygen levels in your blood to the amount of oxygen you are receiving) is between 100 and 300 while using high-flow oxygen or non-invasive ventilation.
The study treatment must begin within 7 days from when you were first admitted to the hospital for community-acquired pneumonia or COVID-19 pneumonia.
You must be receiving standard medical care for community-acquired pneumonia or COVID-19 pneumonia.

Who Cannot Join the Study?

The study information does not provide specific exclusion criteria at this time
You should discuss with the research team whether you are eligible to participate in this study
The study is designed for adults hospitalized with community-acquired pneumonia, which is a lung infection acquired outside of a hospital, or COVID-19 pneumonia, which is a lung infection caused by the coronavirus
General factors that typically prevent participation in clinical trials may include certain medical conditions, medications you are taking, or other health-related reasons that will be discussed during screening

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Groupe Hospitalier Du Sud Ile De France	Melun	France
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Hopital Tenon	Paris	France
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Daugavpils regionala slimnica SIA	Daugavpils	Latvia
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Army Hospital General L. Svoboda Svidnik a.s.	Svidnik	Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.	Michalovce	Slovakia
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
University Of Debrecen	Debrecen	Hungary
Respublikine Siauliu ligonine VÅ¡Ä®	Siauliai	Lithuania
Lietuvos sveikatos mokslu universiteto Kauno ligonine	Kaunas	Lithuania
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Hospital Da Luz S.A.	Lisbon	Portugal
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Respublikine Klaipedos ligonine VšĮ	Klaipeda	Lithuania
Nemocnicna a.s.	Malacky	Slovakia
Hopital Beaujon	Clichy	France
Kardiocentrum Nitra s.r.o.	Nitra	Slovakia
University Of Szeged	Szeged	Hungary
Hopital Nord Franche-Comte	Belfort	France
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Egvzxch	Mechelen	Belgium
Lnjoxcxv supavdjdt mmxvcp uxtvrpnqgtzo Krboj loigkwuz	Kaunas	Lithuania
Sckzukktxnotpsg udpkq swuvmyaac a ciksuzee czuqzl asff	Banska Bystrica	Slovakia
Klkrnplq dch Utvjimtyfpdd Meosjuiw Atb	Munich	Germany
Uctljjwqem Om Asszqrz	Edegem	Belgium
Jvygxvel Kflfyi Uqbyqgvrzn	Linz	Austria
Iboppibu di Cnoqkqxepomy Hzjpqdrrfyn Uamahwgadwogu db Smkuw Ejdqbff (wqlmopa	Saint Priest En Jarez	France
Hfssaxoh Uyvvoaasmmlrko Scbdshmlxw &gwylif Hurortg dx Hhbdxhwyxlz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	22.12.2022
Belgium	Not recruiting	22.12.2022
France	Not recruiting	22.12.2022
Germany	Not recruiting	22.12.2022
Hungary	Not recruiting	22.12.2022
Latvia	Not recruiting	22.12.2022
Lithuania	Not recruiting	22.12.2022
Portugal	Not recruiting	22.12.2022
Slovakia	Not recruiting	22.12.2022

Trial locations

Investigated drugs:

Trimodulin (Human Igm, Iga, Igg Solution)

Trimodulin (also known as BT588) is an investigational medication being tested as an additional treatment alongside standard care for patients hospitalized with pneumonia. It is given to see if it can help improve outcomes in adults with community-acquired pneumonia or COVID-19 pneumonia.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against trimodulin to determine if trimodulin actually works.

Investigated diseases:

COVID-19

Community-Acquired Pneumonia – Community-acquired pneumonia is an infection of the lungs that develops in people who have not been recently hospitalized or exposed to healthcare settings. The infection causes inflammation in the air sacs of the lungs, which may fill with fluid or pus. Symptoms typically include cough, fever, chest pain, and difficulty breathing. The condition can range from mild to severe, depending on the extent of lung involvement and the person’s overall health. It is caused by various bacteria, viruses, or other microorganisms that are contracted outside of hospital environments. The disease progresses as the infection spreads through lung tissue, causing increasing respiratory symptoms.

Coronavirus Disease 2019 – Coronavirus Disease 2019 is a respiratory illness caused by the SARS-CoV-2 virus. The disease primarily affects the lungs but can impact other organs throughout the body. Initial symptoms often include fever, cough, fatigue, and loss of taste or smell. As the disease progresses, some individuals develop pneumonia with increasing difficulty breathing and low oxygen levels. In moderate to severe cases, the infection triggers an excessive immune response that causes widespread inflammation in the lungs. The condition can progress from mild symptoms to severe respiratory distress requiring hospitalization and oxygen support.

Trial ID:

2024-513002-60-00

Protocol code:

1001

NCT ID:

NCT05531149

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing trimodulin in hospitalized adult patients with community-acquired pneumonia including COVID-19 pneumonia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?