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Study of Intravenous Immunoglobulin Added to Standard Treatment for COVID-19 in Patients with Severely Weakened Immune System Due to B-cell Problems

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at COVID-19 in patients who have severely weakened immune systems, specifically those with problems in their B-cells, which are cells that help the body fight infections. The study will test a treatment called Privigen, which contains human normal immunoglobulin given through a vein. This treatment will be added to the standard care that patients normally receive for COVID-19. The standard care may include antiviral medications such as Veklury, which contains remdesivir, or Paxlovid, which contains nirmatrelvir. The study will compare patients who receive Privigen plus standard care to those who receive only standard care.

The purpose of the study is to find out if adding Privigen to standard care helps patients recover from COVID-19 better than standard care alone. The study will specifically look at whether patients recover clinically and whether the virus is cleared from their blood by day 28 after joining the study. Patients in this study will have had COVID-19 symptoms for at least 7 days, will have received full COVID-19 vaccination, and will have the virus present in their blood. They will also have very low levels of antibodies against the virus due to their weakened immune system caused by their disease or treatment.

During the study, patients will be randomly assigned to receive either Privigen added to their standard care or standard care alone. The study will track how well patients are doing using a scale that measures their clinical condition, and will check whether the virus can still be found in their blood at different time points. The study will follow patients for several months to see if they maintain their recovery and to monitor for any side effects or safety concerns related to the treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and randomization
Upon joining the study, your blood will be tested to confirm the presence of SARS-CoV-2 RNA (genetic material of the virus that causes COVID-19) in your blood plasma. This test must be done within 96 hours before you are assigned to a treatment group.
Your anti-SARS-CoV-2 Spike IgG level (antibodies against the virus) will be measured within one week before randomization to confirm it is below the detection limit.
If you are of childbearing potential, a pregnancy test will be performed and must be negative.
You will be randomly assigned to one of two treatment groups: either receiving intravenous immunoglobulin (a solution containing antibodies) added to standard care, or receiving standard care alone.
Step 2
Treatment phase
If assigned to the treatment group, you will receive Privigen (human normal immunoglobulin) 100 mg/ml as an intravenous infusion (given directly into your vein). This is in addition to standard care treatment.
Standard care may include Veklury (remdesivir) 100 mg, given as an intravenous infusion, and/or Paxlovid (nirmatrelvir 150 mg combined with ritonavir 100 mg), taken as film-coated tablets by mouth.
If you are taking Paxlovid and using combined hormonal contraceptives, you will need to use an effective alternative contraceptive method or an additional barrier method during treatment and until one menstrual cycle after stopping the treatment.
If assigned to the standard care only group, you will receive the standard treatments without the addition of intravenous immunoglobulin.
You will not receive any additional treatments specifically targeting SARS-CoV-2 beyond the assigned treatment after randomization.
Step 3
Day 10 assessment
On day 10 after randomization, your clinical condition will be assessed using the WHO Clinical Progression Scale (a standardized scale that measures the severity of COVID-19 symptoms).
Your blood plasma will be tested to check for the presence of SARS-CoV-2 RNA.
Any adverse events (unwanted or harmful reactions) will be recorded, including their frequency, intensity, seriousness, and relationship to the study medication.
Step 4
Day 28 assessment
On day 28 after randomization, your clinical recovery will be evaluated. Clinical recovery is defined as having a score of 0 or 1 on the WHO Clinical Progression Scale, meaning you are either fully recovered or have minimal symptoms.
Your blood plasma will be tested again to determine if SARS-CoV-2 RNA is still detectable.
The assessment will confirm whether you achieved clinical recovery without receiving any additional SARS-CoV-2 directed treatments beyond the standard care assigned at the start.
Your clinical condition will be evaluated to determine if you experienced severe COVID-19 (defined as a score of 6 or higher on the WHO Clinical Progression Scale) at any point up to day 28.
Any adverse events will continue to be monitored and recorded.
Step 5
Day 90 follow-up
On day 90 after randomization, your clinical condition will be assessed to determine if you have maintained sustained clinical recovery (a score of 0 or 1 on the WHO Clinical Progression Scale).
Both your blood plasma and a nasopharyngeal sample (a swab from the back of your nose and throat) will be tested to check for the presence of the original strain of SARS-CoV-2 RNA.
This assessment will verify that you have not received any additional SARS-CoV-2 directed treatments beyond the standard care assigned at randomization.
Step 6
Day 180 final follow-up
On day 180 (approximately 6 months) after randomization, a final assessment will be conducted to evaluate your sustained clinical recovery.
Your blood plasma and nasopharyngeal sample will be tested once more to confirm the absence of the baseline SARS-CoV-2 strain RNA.
Your clinical status will be assessed using the WHO Clinical Progression Scale to ensure you maintain a score of 0 or 1.
This final check will confirm that you have not required any additional SARS-CoV-2 directed treatments beyond the standard care assigned at the beginning of the study.
All adverse events throughout the study period will be reviewed and documented.

Who can join the trial?

9 criteria

You must be 18 years of age or older
You must sign a consent form agreeing to take part in the trial and be available for follow-up visits throughout the study period
You must have COVID-19 symptoms that have lasted for 7 days or longer, regardless of how mild or severe your symptoms are
You must have SARS-CoV-2 RNA (genetic material from the virus that causes COVID-19) detected in your blood plasma (the liquid part of your blood) within 96 hours (4 days) before being assigned to a treatment group. This test is called RT-PCR, which is a laboratory test that detects the virus
You must have received a complete initial COVID-19 vaccination series, meaning at least two doses of any COVID-19 vaccine, at least four weeks before joining the trial
You must have severely impaired B-cell function. B-cells are white blood cells that help your body fight infections by making antibodies. This impairment can be due to a disease you have or treatments you are receiving, such as blood cancer, medicines given after receiving an organ transplant to prevent rejection, or current or past treatment with anti-CD20 medicines (a type of antibody treatment that affects B-cells)
Your blood test must show that your level of anti-SARS-CoV-2 Spike IgG (antibodies against the COVID-19 virus) is below the level needed to be considered positive. This test must be done within one week before being assigned to a treatment group
If you are a person of childbearing potential (able to become pregnant), you must have a negative pregnancy test
If you are a person of childbearing potential, you must use highly effective birth control methods while receiving antiviral medicines for COVID-19. These methods include hormonal birth control pills or devices, an intrauterine device, not having sexual intercourse, or using barrier methods like condoms with spermicide. If you are taking a specific antiviral medicine called Nirmatrelvir/Ritonavir and use hormonal birth control pills, you will need to use an additional or alternative birth control method during treatment and until one menstrual cycle after stopping the medicine

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent someone from joining this clinical trial
Typically, exclusion criteria might include things like certain other medical conditions, use of specific medications, or laboratory test results that fall outside acceptable ranges, but these are not specified in the available information

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Danderyds Sjukhus AB
Verified
Danderyd, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

Privigen is an intravenous immunoglobulin medication, also known as IVIg. This medicine contains antibodies collected from healthy blood donors. It is given through a vein to help boost the immune system in patients who have weakened immunity. In this trial, it is being tested as an additional treatment for patients with COVID-19 who have severely impaired B-cell function, which means their bodies have difficulty producing their own antibodies to fight infections.

What is already known about the treatment

Privigen – Privigen is an intravenous immunoglobulin (IVIg) medication that is administered directly into the bloodstream through an infusion. It contains antibodies collected from healthy blood donors and is currently being studied as an additional treatment alongside standard care for COVID-19 patients who have severely weakened immune systems, specifically those with impaired B-cell function who cannot respond properly to vaccines. The medication works by providing ready-made antibodies that help the body fight infections, essentially supplementing the patient's own immune system which cannot produce enough protective antibodies due to B-cell dysfunction. Privigen belongs to the class of immunoglobulin replacement therapies and is designed to help these vulnerable patients recover from COVID-19 and clear the virus from their bloodstream more effectively.

Investigated diseases

COVID-19
COVID-19 is an infectious disease caused by the SARS-CoV-2 virus that primarily affects the respiratory system. The disease can range from mild symptoms like fever, cough, and fatigue to more severe forms involving breathing difficulties and pneumonia. In some cases, the infection can progress to severe respiratory distress requiring hospitalization and oxygen support. The virus spreads through respiratory droplets when an infected person coughs, sneezes, or talks. People with weakened immune systems may experience prolonged infection and difficulty clearing the virus from their body. The disease progression is monitored using clinical scales that measure the severity of symptoms and the patient's functional status.
B-cell Immunodeficiency
B-cell immunodeficiency is a condition where the immune system has a severely reduced ability to produce B-cells, which are white blood cells responsible for making antibodies. Without adequate B-cell function, the body cannot effectively fight off infections or respond properly to vaccines. This condition leaves affected individuals vulnerable to repeated and prolonged infections, particularly from bacteria and viruses. The impaired immune response means that standard vaccinations may not provide the expected protection. People with this condition often experience frequent respiratory and other infections that can be more severe than in healthy individuals. The severity of the condition depends on how significantly the B-cell function is reduced.