AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

efficacy and safety of the use of regulatory T cells in immune hyperactivation in patients with COVID-19 and/or acute respiratory distress syndrome

This research is investigating a new type of treatment using special cells from the immune system, called regulatory T cells. Doctors are studying this treatment for people who are very unwell because their immune system is overreacting to COVID-19, or they have a serious lung condition known as Acute Respiratory Distress Syndrome (ARDS). This overreaction can make them feel much worse. The study is in its early stages (Phase I and II), which means it's one of the first times this treatment is being given to people. The main goal is to find out if the treatment is safe for patients and if it can help to reduce the harmful over-activity of the immune system, potentially leading to better recovery.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

Enrolment target

Start

30 Jan 2025

immune hyperactivation in COVID-19 patients and/or acute respiratory distress syndrome

What is this study about?

This study is trying to find a new way to help people who are seriously ill with COVID-19 or a severe lung condition called Acute Respiratory Distress Syndrome (ARDS). When you get sick, your immune system usually springs into action to fight off the illness. However, sometimes, especially with severe COVID-19 or ARDS, the immune system can become overactive and start to cause more harm than good, leading to further damage in the body, particularly the lungs. This is what doctors call 'immune hyperactivation'.

The researchers are looking at a treatment that uses special cells from our own bodies called 'regulatory T cells'. These cells are like the peacekeepers of the immune system; their job is to calm down immune responses and stop them from overreacting. The idea is that by giving more of these regulatory T cells to people whose immune systems are in overdrive, it might help to reduce the harmful inflammation and damage, allowing them to recover better.

Because this is a new type of treatment, the study is in its early stages (Phase I and II). This means it's one of the first times doctors are giving this treatment to people. The main goals are to check if the treatment is safe for patients and then to see if it has any positive effects on their condition.

Key takeaways

This study explores a new cell-based treatment for severe COVID-19 or ARDS.
It aims to calm an overactive immune system causing harm.
The treatment uses special cells called regulatory T cells.
It’s an early-stage study, focusing on safety and initial effectiveness.
Participation involves close monitoring by a medical team.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults are welcome to be considered too. Both men and women can participate in this research.

Critically, you would need to be currently experiencing an overactive immune response because of COVID-19, or have a severe lung condition called Acute Respiratory Distress Syndrome (ARDS). This study is specifically for people whose immune system is reacting too strongly, causing problems.

Quick self-check

Are you 18 years old or older?
Are you currently suffering from severe COVID-19 or a lung condition called ARDS?
Has a doctor told you that your immune system is overreacting?
Are you open to trying a new, experimental treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be amongst the first people to receive this new treatment. We expect that you would have several visits to the hospital for doctors to carefully monitor your health and how you respond to the treatment. This will include regular blood tests, checks of your breathing and other vital signs, and possibly some scans to see how your lungs are doing. The exact number of visits and tests will depend on your individual health needs and how long you are in the study. You will be closely looked after by a medical team throughout your time on the trial. The total length of your participation would be explained in full by the study team, but it would involve initial treatment and then follow-up to see how you are recovering.

Potential risks and benefits

Taking part in any new treatment study carries both potential benefits and risks. You might benefit if this new treatment helps to calm your overactive immune system and improves your recovery from COVID-19 or ARDS, potentially leading to better outcomes than standard care. However, because it's a new treatment, there could be side effects that doctors don't fully know about yet. These could range from mild to serious, and the research team will explain all known possibilities. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Spain

Common questions

What are 'regulatory T cells'?

They are special cells in your immune system that help to calm down immune reactions and prevent your body from overreacting to an illness.

What is 'immune hyperactivation'?

This is when your immune system goes into overdrive and causes too much inflammation or damage, which can make you sicker.

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a very serious lung condition where your lungs are severely inflamed and struggle to get enough oxygen into your blood.

Is this treatment already available?

No, this is an investigational treatment being studied in a clinical trial. It's not yet available for general use.

Will I get COVID-19 if I join this study?

This study is for people who are already unwell with COVID-19 or ARDS. Taking part would not give you the illness, but aims to help manage it.