AuthorisedTherapeutic exploratory (Phase II)Interventional

Randomized Open Label Trial Evaluating Efficacy and Safety of Intravenous Immunoglobulin (IVIg, Privigen) as Add-on to SoC Versus SoC Alone for Coronavirus Disease 2019 (COVID-19) in Patients with Severely Impaired B-cell Function

This research study is looking at a medicine called Privigen, given as a drip, for adults with COVID-19. It's for people whose immune system has trouble fighting off infections (called 'severely impaired B-cell function'). The study wants to find out if adding Privigen to the usual COVID-19 care helps people recover faster and clears the virus more effectively than just having the usual care. Researchers will be checking how many people recover fully and have no sign of the virus in their blood after 28 days. They will also look at whether the treatment is safe and if it causes any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Vaesterbotten, Umea University

Enrolment target

Start

06 Feb 2026

COVID-19 and Severely Impaired B-cell Function

What is this study about?

This research study is about finding better ways to treat COVID-19, especially for people who have a specific problem with their immune system. Your immune system is your body's natural defense against illnesses, and some people have a weakened part of it (called 'severely impaired B-cell function'). This means their body struggles more to fight off viruses like COVID-19.

The study is testing a medicine called Privigen, which is given as a drip into your vein. Privigen is a type of medicine that helps support your immune system. The researchers want to see if adding this medicine to the standard care for COVID-19 helps people with weakened immune systems recover more fully and get rid of the virus faster compared to those who only receive the standard care. Standard care might include other medicines like Veklury or Paxlovid, which are also used to treat COVID-19.

This is a 'Phase II' study, which means it's an earlier stage of research where doctors are carefully looking at how well the new treatment works and if it's safe. They will be closely monitoring participants to understand the effects of Privigen and gather important information to help future patients.

Key takeaways

This study tests a new treatment (Privigen) for COVID-19 in people with weakened immune systems.
It aims to see if Privigen, added to standard care, helps people recover faster and clear the virus.
Participants will be randomly assigned to receive Privigen or standard care only.
The study looks at both the effectiveness and safety of the new treatment.
It involves regular health checks and tests over several months.

Who may be eligible?

To join this study, people must be 18 years old or older. The study is open to both men and women.

The main thing researchers are looking for is if you have COVID-19 and also a specific immune system problem where your body struggles to make enough 'B-cells' – these are important cells that help fight off infections.

Before you can join, a doctor will need to check your health to make sure this study is right for you and that taking part would be safe.

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.

Are you 18 years old or older?
Do you currently have COVID-19?
Has a doctor told you that you have a problem with your immune system's 'B-cells'?
Are you able to attend regular follow-up appointments and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups. One group would receive Privigen as a drip in addition to the standard care for COVID-19, while the other group would receive standard care only. You wouldn't be able to choose which group you are in.

The study involves regular visits and checks over several months. Doctors would take blood samples to look for the virus and check your progress. They would also keep a close eye on your overall health, how your COVID-19 symptoms are changing, and if you experience any side effects. The main period of treatment and close monitoring would be for about 28 days after starting, but follow-up checks would continue for up to 180 days (about 6 months) to see how you are doing in the long term and confirm that the virus has been cleared from your system. You would also have some nasal swabs taken.

Potential risks and benefits

Potential benefits of joining could include receiving a new treatment that might help you recover from COVID-19 more effectively, especially if your immune system is weakened. However, there's no guarantee that the treatment will work for everyone, or that it will be better than standard care. As with any medicine, there's a risk of side effects from Privigen, and the research team would explain these to you. You would also have more doctor appointments and tests than usual as part of the study. Remember, taking part in any clinical trial is always your choice, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is 'severely impaired B-cell function'?

This means your immune system has trouble making enough 'B-cells,' which are important cells that help your body fight off infections like COVID-19.

What is Privigen?

Privigen is a medicine given through a drip that helps support your immune system's ability to fight infections.

Will I definitely get the new medicine?

No, you would be randomly assigned to either receive Privigen plus standard care, or standard care alone. It's like flipping a coin, so you wouldn't get to choose.

How long will the study last for me?

You'll be closely checked for about a month, but doctors will follow up on your health and check-ups for around 6 months after you start.

What is 'standard care' for COVID-19?

Standard care means the usual treatments doctors give for COVID-19, which might include specific antiviral medicines like Veklury or Paxlovid.