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Immune Modulation by Exosomes in COVID-19

This research is investigating COVID-19 in patients who are critically ill with severe lung problems. Sometimes, in these patients, the body's immune system overreacts, causing a lot of inflammation and damage to the lungs, making it hard to breathe. We're looking at tiny biological messengers called exosomes, which come from special 'mesenchymal stem cells'. These exosomes are known to have properties that can calm down inflammation and help repair tissues. In this study, we will take blood samples from critically ill COVID-19 patients and see how their immune cells react when these exosomes are added. We want to find out if these exosomes can reduce harmful inflammation markers and promote healing pathways in the blood, potentially offering new ways to treat severe COVID-19.

At a glance

Status
Recruiting
Sponsor
University of Ulm
Enrolment target
40
Start
22 Dec 2021
Estimated completion
31 Dec 2026

What is this study about?

When people get very sick with COVID-19, especially those who end up in intensive care, their bodies can have a strong and harmful reaction. This is often an overactive immune response, which doctors sometimes call a 'cytokine storm' or 'hyperinflammation'. This excessive inflammation can severely damage organs, particularly the lungs, leading to conditions like acute respiratory distress syndrome (ARDS), where patients can't breathe properly and might need machines to help them.

At the same time, this inflammation can also cause scarring in the lungs, known as lung fibrosis. This scarring makes the lungs stiff and even harder to work, potentially leading to long-term breathing problems. Current treatments for these severe complications are limited, highlighting the need for new approaches to help these patients recover.

This study is exploring a new idea involving tiny natural messengers called 'exosomes'. These exosomes are released by special cells in our bodies called 'mesenchymal stem cells', which are known for their ability to calm inflammation and help repair damaged tissues. We are studying whether these exosomes can reduce the harmful inflammation and encourage healing in the blood of severely ill COVID-19 patients. We want to understand if these exosomes could be a way to dampen the dangerous immune overreaction and prevent further lung damage, ultimately improving outcomes for these patients.

Key takeaways

  • This study helps understand severe COVID-19 complications.
  • It investigates tiny messengers called 'exosomes' as potential immune balancers.
  • The research uses blood samples from very sick COVID-19 patients.
  • Findings could lead to new treatments for inflammation and lung damage.
  • Participation involves only a standard blood test, no new medicines.
  • The study aims to reduce hyperinflammation and lung scarring.

Who may be eligible?

To be considered for this study, you would need to be an adult between 18 and 90 years old and weigh more than 50 kg (around 7 stone 12 pounds). You would also need to be critically ill with COVID-19, meaning your illness is very serious and affecting your lungs significantly, requiring substantial medical support.

It's also important that your doctors have diagnosed you with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, which is a specific type of severe lung injury. If you meet these conditions, and you are able to understand and agree to take part by giving your informed consent, you might be eligible.

However, some people will not be able to participate. This includes pregnant women or those who are breastfeeding. The study involves blood tests only, not a new treatment being given to you directly.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 90 years old?
  2. Do you weigh more than 50 kg (about 7 stone 12 pounds)?
  3. Have you been diagnosed with severe COVID-19 affecting your lungs?
  4. Are you critically ill, needing significant medical care?
  5. Are you pregnant or breastfeeding? (If so, you cannot participate)
  6. Can you give your agreement to take part after understanding the study?
Answer every question to see your result.

What does participation involve?

This study involves a laboratory test using your blood. If you are eligible and agree to take part, a blood sample will be taken. This blood sample will then be used in the lab to see how your immune cells react when exosomes are added. You won't receive any new medication or treatment as part of this study, nor will you need extra hospital visits. It's a single blood sample, and there's no ongoing follow-up for you related to this research. The study will analyse the blood sample for immune response, cytokine levels (markers of inflammation), and gene activity. The entire involvement for you as a patient would be the single blood draw.

Potential risks and benefits

Taking part in this study may not directly benefit your health, as it is a laboratory-based study using blood samples to understand the disease better. However, the information gained could help researchers develop better treatments for future patients with severe COVID-19. The main risk involved is the standard discomfort and very small risk of bruising or infection from a blood draw, which is a common medical procedure. You are free to withdraw your consent to participate at any time without affecting your medical care.

Locations (1)

  • Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine
    Verified postcode
    Ulm, Germany· Recruiting

Common questions

What are exosomes?

Exosomes are tiny bubble-like messengers released by cells that carry proteins and genetic material. They help cells communicate with each other.

What are mesenchymal stem cells?

These are special cells found in the body that can develop into different cell types and are known for their ability to reduce inflammation and help repair tissues.

Will I receive exosomes as a treatment?

No, this study does not involve giving you exosomes. It's a lab study using your blood to see how exosomes affect your immune cells.

Why is lung fibrosis important?

Lung fibrosis is scarring in the lungs that can make them stiff and very hard to breathe, leading to long-term breathing problems after severe COVID-19.

What does 'critically ill' mean in this study?

It means patients with very serious COVID-19 who have severe lung problems, often requiring intensive care and significant medical support.

How to find out more

Manfred Weiss, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Immune Modulation by Exosomes in COVID-19…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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