Study on the Safety of Mercaptamine with Standard Therapy for Hospitalized COVID-19 Pneumonia Patients Not Requiring High Oxygen Flows

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What is this study about?

This clinical trial is focused on studying the effects of a medication called cysteamine in patients who have been hospitalized with COVID-19 pneumonia. COVID-19 is a respiratory illness caused by the coronavirus, which can lead to severe lung infections. The trial aims to evaluate the safety of cysteamine when used alongside standard treatments for COVID-19 pneumonia. Cysteamine is being tested to see if it can help improve the condition of patients who do not require high levels of oxygen support.

Participants in the study will receive cysteamine in the form of hard capsules, taken orally. The study will monitor patients over a period of time to observe any side effects and to assess how the medication interacts with the body. The trial will also track the number of days it takes for patients to recover and be discharged from the hospital. The goal is to determine if cysteamine can be a safe and effective addition to the current treatment options for COVID-19 pneumonia.

Throughout the study, various health indicators will be measured, such as blood markers and the presence of the virus in the body. The trial will also look at how cysteamine affects the expression of certain genes related to the immune response. By the end of the study, researchers hope to gather valuable information on the potential benefits of cysteamine for patients with COVID-19 pneumonia.

1 beginning of the trial

Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the trial.

You will undergo a series of initial assessments to confirm eligibility, including a nasopharyngeal swab to test for SARS-CoV-2, and imaging examinations like X-ray or CT scan to check for COVID-19 pneumonia.

2 medication administration

You will receive CYSTAGON 150 mg hard capsules containing the active substance mercaptamine. This medication is taken orally.

The dosage and frequency of the medication will be determined by the study team, and you will be informed about how and when to take the capsules.

3 monitoring and follow-up

Throughout the trial, your health will be closely monitored. This includes regular check-ups and assessments to track your response to the medication.

Blood samples will be taken at specific intervals, such as at the start, and on days 3, 7, and 28, to measure cytokines and other blood markers.

4 end of treatment

The primary treatment phase lasts up to 10 days, or until you are discharged from the hospital, whichever comes first.

You will be asked to report any side effects or changes in your condition during this period.

5 post-treatment follow-up

After completing the treatment, follow-up visits will be scheduled at 28 and 90 days to assess your health and any long-term effects of the medication.

You will be asked to continue reporting any side effects or health changes during this time.

Who Can Join the Study?

Age must be 18 years or older.
If you are infertile (cannot have children) due to menopause or surgery (like vasectomy for men or tubal closure for women), you can participate. If you can have children, you must have a negative pregnancy test (for women) and agree to use contraception from 2 weeks before joining the study until 18 weeks after receiving the study drug.
You must have a positive test for COVID-19 from a nose or throat swab.
Your COVID-19 symptoms must have started 10 days ago or less.
You must have signs and symptoms of COVID-19 pneumonia (lung infection caused by COVID-19).
An imaging test (like X-ray, ultrasound, or CT scan) of your chest must show COVID-19 pneumonia, but you should not need high levels of oxygen support.
You must be receiving low-flow oxygen support through a Venturi mask or goggles, with a specific oxygen level measurement (pO2/FiO2 ratio) greater than 200 mmHg.
Your body weight must be 50 kg or more.
You must be able to provide informed consent, meaning you understand the study and agree to participate.
You must be able to attend follow-up visits as required by the study.

Who Cannot Join the Study?

Patients who are currently experiencing any infectious diseases of the respiratory system, such as COVID-19, cannot participate.
Patients who require high levels of oxygen support are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
National Institute For Infectious Diseases Lazzaro Spallanzani	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	23.02.2024

Trial locations

Investigated drugs:

Mercaptamine

Cysteamine is a medication being studied for its potential to help treat patients with COVID-19 pneumonia. It is being tested to see if it is safe for people who are in the hospital with this condition. Cysteamine is thought to have antiviral properties, which means it might help fight the virus that causes COVID-19. It is also being looked at for its ability to directly affect the body in a way that could help patients recover from the pneumonia caused by the virus. This study is particularly focused on patients who do not need high levels of oxygen support, regardless of whether they have been vaccinated against COVID-19.

Investigated diseases:

COVID-19 – COVID-19 is an infectious disease caused by the SARS-CoV-2 virus, primarily affecting the respiratory system. It begins with symptoms such as fever, cough, and fatigue, and can progress to more severe respiratory issues like pneumonia. The disease spreads through respiratory droplets and can lead to complications in various organs. As it progresses, some patients may experience difficulty breathing, chest pain, and loss of taste or smell. In severe cases, it can cause acute respiratory distress syndrome (ARDS) and require hospitalization. The progression and severity of symptoms can vary widely among individuals.

Trial ID:

2024-516800-40-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Mercaptamine with Standard Therapy for Hospitalized COVID-19 Pneumonia Patients Not Requiring High Oxygen Flows

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?