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Study on Anti-COVID-19 Hyperimmune Globulin for Treating Adults with Early COVID-19 Symptoms

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What is this trial about?

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

This clinical trial is focused on studying the treatment of COVID-19, a disease caused by the SARS-CoV-2 virus. The treatment being tested is called Anti-COVID-19 Hyperimmune Globulin (Human), also known by its code name COVID-HIGIV. This treatment is a special type of medicine made from antibodies, which are proteins that help the body fight infections. The study aims to see how safe and effective this treatment is for adults who have recently been diagnosed with COVID-19 and are in the early stages of the disease.

Participants in the study will receive a single dose of the treatment through an intravenous infusion, which means it is given directly into a vein. Some participants will receive a placebo instead of the actual treatment. The study will compare the health status of participants after seven days to see if the treatment helps improve their condition. The study will also look at how the treatment affects the need for hospitalization and the overall health of participants over a period of 28 days.

The goal is to determine if the Anti-COVID-19 Hyperimmune Globulin (Human) can help reduce the severity of COVID-19 symptoms and prevent the disease from getting worse. The study will include participants who are at higher risk due to age or other health conditions. By testing this treatment, researchers hope to find a new way to help people recover from COVID-19 more quickly and with fewer complications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must provide written informed consent. This indicates understanding and agreement to adhere to the study procedures through Day 28.
Eligibility is based on age (55 years or older) or being an adult with an immunosuppressed condition, a positive test for SARS-CoV-2 within 5 days, and symptom onset within 5 days if symptomatic.
Step 2
Treatment administration
The participant receives a single infusion of Anti-COVID-19 Hyperimmune Globulin (Human) or a placebo. This is administered through an intravenous infusion, which means the solution is delivered directly into the vein.
The infusion is given alongside standard care, which may include other treatments as recommended by COVID-19 treatment guidelines.
Step 3
Monitoring and follow-up
The participant's health status is monitored over a period of 28 days. This includes assessing symptoms and any limitations in usual activities due to COVID-19.
Health assessments occur at specific intervals: Day 4, Day 7, Day 14, and Day 28. These assessments evaluate the severity of symptoms, progression of the disease, and any changes in health status.
Step 4
Evaluation of outcomes
Primary outcomes focus on the participant's clinical status after seven days, comparing those who received the hyperimmune globulin to those who received a placebo.
Secondary outcomes include hospitalization or death through 28 days, changes in viral burden and antibody levels, and the use of healthcare resources.

Who can join the trial?

5 criteria

The patient must be at least 55 years old, or at least 18 years old if they have a condition that weakens their immune system.
The patient must have tested positive for the virus that causes COVID-19 (SARS-CoV-2) within the last 5 days. This can be confirmed by a specific type of test called a nucleic acid amplification test (NAAT) or any approved rapid test.
If the patient has symptoms from the current COVID-19 infection, these symptoms must have started within the last 5 days.
The patient must agree not to join another clinical trial for COVID-19 treatment or management until 7 days have passed, or until they are hospitalized or their condition worsens significantly before the 7 days are up.
The patient must provide written consent, meaning they agree in writing to participate in the study and follow the study procedures for 28 days.

Who cannot join the trial?

3 criteria

Patients who have received a **direct-acting antiviral (DAA)** or other anti-SARS-CoV-2 agent as part of their standard care treatment. **Direct-acting antivirals** are medications that directly target the virus to stop it from multiplying.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population that the study is not designed to include. **Vulnerable populations** may include groups like pregnant women, children, or those with certain health conditions.

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Alexandra Hospital
Verified
Athens, Greece

Trial locations

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Investigated drugs

Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin (hIVIG)
is a treatment being tested for its safety and effectiveness in adults who have recently been diagnosed with COVID-19. This medication is given as a single infusion and is designed to help the immune system fight the coronavirus by providing concentrated antibodies from people who have recovered from the virus. The goal is to improve the patient's clinical status after seven days of treatment.
Direct-Acting Antiviral (DAA)
is a type of medication that may be included in the standard care for some participants in the trial. These medications work by directly targeting the virus to stop it from multiplying in the body. They are part of the recommended treatments for COVID-19 according to national or international guidelines.
Other Anti-SARS-CoV-2 Agents
are treatments that may also be part of the standard care for participants. These agents are used to combat the coronavirus and are recommended by health authorities as part of the treatment plan for COVID-19. They work in various ways to help reduce the severity of the infection.

Anti-Sars-Cov-2 Polyclonal Hyperimmune Globulin

What is already known about the treatment

Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin (hIVIG) – This medication is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its safety and effectiveness in treating early-stage COVID-19 in adults. The main therapeutic indication is to improve clinical status in patients recently diagnosed with SARS-CoV-2 infection. At the molecular level, hIVIG works by providing concentrated antibodies that can neutralize the virus, potentially reducing its ability to cause disease. It is classified pharmacologically as an immunoglobulin therapy, which is a type of treatment that uses antibodies to help the immune system fight infections.

Investigated diseases

COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. It can range from asymptomatic cases to severe respiratory distress. The disease often begins with symptoms like fever, cough, and fatigue, and may progress to more severe conditions such as pneumonia or acute respiratory distress syndrome. Some individuals experience mild symptoms, while others may face significant limitations in daily activities. Severe cases can lead to critical illness, requiring intensive medical care. The progression and severity of the disease can vary widely among individuals.