Study on ITPP and Sodium Chloride for Patients with COVID-19 and Other Lung Infections Facing Breathing Problems

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people suffering from COVID-19 and other lung infections that cause breathing problems. The treatment being tested is called OXY111A, which contains a substance known as inositol trispyrophosphate hexasodium. This treatment is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream. Another solution used in the study is a common medical fluid called sodium chloride, which is often used in hospitals to help deliver medications.

The purpose of this study is to see if the treatment can help improve breathing in patients who are experiencing severe respiratory failure, which means their lungs are not working well enough to get oxygen into the blood. The study will involve patients who are hospitalized with pneumonia caused by SARS-CoV-2 (the virus responsible for COVID-19) or other similar infections. The trial will last for a short period, with the treatment being given over a maximum of seven days.

Throughout the study, researchers will monitor the patients’ breathing and other health indicators to see if there is an improvement. They will also check how well patients tolerate the treatment and if there are any side effects. The goal is to find out if this new treatment can be a helpful addition to the current care for people with severe lung infections. The study is expected to continue until mid-2025.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and imaging to diagnose pneumonia and respiratory failure caused by SARS-CoV-2 or other pathogens.

Eligibility criteria include being 18 years or older, having a neutrophil count above 500/ml, a platelet count above 50,000/ml, and specific levels of bilirubin, creatinine, ALT, and AST within defined limits.

2 treatment administration

The treatment involves the administration of OXY111A, which contains inositol trispyrophosphate hexasodium and sodium chloride. This is given as a solution for infusion or solution for injection through intravenous use or intravenous infusion.

The treatment aims to improve respiratory capacity by enhancing gasometric and biochemical parameters.

3 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess the improvement in respiratory capacity and to evaluate the safety and tolerance of the treatment.

Primary endpoints focus on the improvement of respiratory capacity, while secondary endpoints assess the safety profile and tolerance of the treatment.

4 completion of trial

The trial is estimated to conclude by June 30, 2025. Upon completion, data collected will be analyzed to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

Patients must be hospitalized with pneumonia and breathing problems caused by the COVID-19 virus or other germs. Pneumonia is determined by a doctor through your medical history, a physical check-up, and imaging tests like X-rays.
Patients must be at least 18 years old.
Patients need to have a neutrophil count (a type of white blood cell) above 500 per microliter of blood.
Patients need to have a platelet count (cells that help with blood clotting) above 50,000 per microliter of blood.
Patients’ total bilirubin (a substance made by the liver) and creatinine levels (a waste product from muscles) should not be more than three times the normal range.
Patients’ ALT and AST levels (enzymes that show liver health) should not be more than five times the normal range.
Patients must have worsening severe breathing problems that need strong mechanical help to breathe within 14 days of being admitted to the hospital. This is confirmed if the patient has two of the following at the same time:
- A breathing rate over 35 breaths per minute.
- Low oxygen levels in the blood (below 60 mm Hg) even with oxygen therapy using a mask with a reservoir.
- Acute respiratory acidosis, which means the blood is too acidic due to breathing problems.
- A paO2 / fO2 ratio (a measure of lung function) below 150 mmHg.
- Changes in consciousness, meaning the patient might be confused or not fully alert.

Who Cannot Join the Study?

Patients with COVID-19 or other infections affecting the lungs cannot participate. Lungs are the organs in your chest that help you breathe.
Patients who are not within the specified age range for the study cannot participate. Age range refers to the specific ages that are allowed in the study.
Patients who do not meet the gender requirements cannot participate. Gender refers to whether you are male or female.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable population means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	15.04.2023

Trial locations

ITPP is being studied as an additional treatment for patients experiencing worsening respiratory failure due to COVID-19 and other lung infections. The goal of using ITPP in this trial is to help improve the patients’ ability to breathe by enhancing their respiratory capacity. This is measured by looking at specific gas and chemical levels in the blood to see if there is an improvement.

Investigated diseases:

COVID-19

COVID-19 – COVID-19 is a respiratory illness caused by the coronavirus SARS-CoV-2. It primarily affects the lungs, leading to symptoms such as fever, cough, and difficulty breathing. The virus spreads through respiratory droplets and can cause mild to severe symptoms. In some cases, it can lead to pneumonia and acute respiratory distress syndrome. The disease can progress rapidly, especially in individuals with underlying health conditions. Recovery times vary, and some individuals may experience lingering symptoms.

Pulmonary Parenchyma Infections – Pulmonary parenchyma infections refer to infections that affect the lung tissue itself. These infections can be caused by bacteria, viruses, or fungi and often result in inflammation and fluid accumulation in the lungs. Symptoms typically include cough, fever, chest pain, and difficulty breathing. The progression of these infections can vary depending on the causative agent and the individual’s overall health. In severe cases, they can lead to complications such as abscess formation or respiratory failure. Early detection and management are crucial to prevent further lung damage.

Trial ID:

2024-517878-21-00

Protocol code:

ABM/COVID19/0034

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on ITPP and Sodium Chloride for Patients with COVID-19 and Other Lung Infections Facing Breathing Problems

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?