Active not recruitingNAINTERVENTIONAL

Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19

This research study is investigating a new treatment device called Seraph 100. It's designed to help people who have COVID-19. The main goal is to find out if this device is safe to use and if it works well in treating patients with the virus. The study is being carried out in hospitals in Germany and Spain. Patients taking part will be split into two groups: one group will receive treatment with the Seraph 100 device plus the usual care they would get for COVID-19, and the other group will only receive the usual care. Doctors will then compare how both groups fare over a 28-day period to see if the Seraph 100 makes a difference.

At a glance

Status

Active not recruiting

Phase

Sponsor

ExThera Medical Corporation

Enrolment target

Start

04 May 2021

Estimated completion

30 Jun 2027

COVID-19

What is this study about?

This study is called the 'Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19'. It's looking at a new medical device called the Seraph 100 Microbind Affinity Blood Filter. The aim is to see if this device is both safe to use and effective in helping people who have tested positive for COVID-19. They are trying to find out if it can improve how well patients recover from the virus.

This important research is taking place in several hospitals in Germany and Spain. Patients who agree to join the study will be randomly put into one of two groups. One group will receive the Seraph 100 device alongside their usual COVID-19 care. The other group will just receive the usual care. This allows the researchers to fairly compare the new device against the standard treatment.

For 28 days after starting treatment, patients' health will be carefully monitored. Blood samples will be taken at the beginning of the study and 12 hours later to check how the virus is progressing. This will help doctors understand if the Seraph 100 device is making a positive impact on patients with COVID-19.

Key takeaways

This study evaluates a device called Seraph 100 for COVID-19 treatment.
It aims to check both safety and how well the device works.
Patients will be in one of two groups: device plus care, or care only.
The study lasts for 28 days.
It is taking place in hospitals in Germany and Spain.

Who may be eligible?

To join this study, you must have a confirmed COVID-19 infection and be between 18 and 90 years old. You also need to be experiencing severe breathing problems (doctors call this acute respiratory distress syndrome) and have at least one other organ in your body struggling due to the infection. It's also important that you are able to understand the study and willingly give your written or electronic permission to take part.

There are some reasons why you might not be able to join. For example, if you are already in another research study, are pregnant or breastfeeding, or planning to become pregnant during the study period, you wouldn't be eligible. If your doctors believe you have other serious health problems that could make it unsafe for you to join or affect the study's results, you also can't take part.

Additionally, you cannot join if you have a severe liver condition called Child-Pugh Class C cirrhosis, or a very low platelet count (blood cells that help stop bleeding). If you can't be given a common blood thinner called heparin, or if you have allergies to certain materials like polyethylene and copolyester, you would also be excluded. Finally, if your COVID-19 infection was caught in the hospital, or if you are in any situation where your decision to join wouldn't be truly voluntary, you won't be able to participate.

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.

Do you have a confirmed COVID-19 infection?
Are you between 18 and 90 years old?
Are you experiencing severe breathing difficulties due to COVID-19?
Do you have other organs being affected by the infection?
Are you able to understand and agree to participate willingly?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will first be randomly assigned to one of two groups: either the group receiving the Seraph 100 device plus usual care, or the group receiving only usual care. Doctors and nurses will monitor your health closely for 28 days.

This will involve taking blood samples: one just before your treatment starts (or soon after joining for the usual care group), and another sample 12 hours later. You will continue to receive the standard medical care for your COVID-19 condition throughout the study. The total duration of your active participation, specifically for monitoring related to this study, will be 28 days.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that the Seraph 100 device might help improve your condition if you are in the treatment group, though this is not guaranteed as it's still being evaluated. All study participants will receive careful medical attention throughout the 28-day period. Potential risks might include any side effects from the Seraph 100 device, or the usual risks associated with receiving standard medical treatment for COVID-19. However, the study aims to ensure the device is safe. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Klinikum Aschaffenburg-Alzenau
Verified postcode
Aschaffenburg, Germany
Vivantes Klinikum Neukölln
Verified postcode
Berlin, Germany
Universitätsklinikum Essen
Verified postcode
Essen, Germany
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain
Hospital Clinico San Carlos
Verified postcode
Madrid, Spain

Common questions

What is Seraph 100?

Seraph 100 is a special blood filter device that researchers are testing to see if it can help people with COVID-19.

Where is this study happening?

This study is being carried out in hospitals in Germany and Spain.

How long will I be in the study?

If you join, your health will be monitored for 28 days as part of the study.

What does 'standard of care' mean?

Standard of care means the usual medical treatments and care that doctors give to patients with COVID-19.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical treatment.