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IBUZATRELVIR

Clinical trials are studying IBUZATRELVIR in people with COVID-19, including adults and adolescents who are not hospitalized but are at risk for severe disease, and adults with a severely weakened immune system. These studies are checking whether IBUZATRELVIR can improve outcomes such as hospital visits, hospitalization, death, and signs of ongoing infection.

Table of contents

Trial overview

Two authorised Phase 3 clinical trials are studying IBUZATRELVIR in people with COVID-19.[1][2] One trial is in nonhospitalized adults and adolescents who are at high risk for severe disease, and the other is in adults with a severely compromised immune system.[1][2]

Who is being studied

The first study includes adult and adolescent patients with COVID-19 who are not in the hospital but may be more likely to become seriously ill.[1] The second study includes symptomatic adults with COVID-19 who are severely immunocompromised, which means their immune system is very weak.[2]

These groups are important because they may need extra protection against worsening illness or ongoing infection.[1][2]

Trial design and phase

Both studies are interventional, which means researchers give study treatment and then measure the results.[1][2] Both are in Phase 3, a later stage of research that usually tests a treatment in larger groups and compares it with placebo or another active treatment.[1][2]

The first study plans to enroll 2,330 participants, while the second study plans to enroll 300 participants.[1][2] Both studies are currently listed as authorised.[1][2]

What the trials measure

The main result in the first study is the proportion of participants who have a COVID-19-related emergency department visit, receive supplemental oxygen, receive antiviral or intravenous treatment, are hospitalized, or die from any cause by Day 28.[1] This is a composite endpoint, which means several important events are grouped into one main outcome.[1]

The second study uses a similar main outcome by Day 38, including emergency department visits, hospitalization, or death, and it also looks for evidence of recurrent or persistent SARS-CoV-2 infection.[2] This means the study is checking both clinical recovery and whether the virus is still present or comes back.[2]

Study comparisons and treatment groups

The first trial compares IBUZATRELVIR with placebo, which is an inactive treatment used for comparison.[1] The trial description says the study medicine is given as a film-coated tablet, and the comparison group receives placebo.[1]

The second trial studies IBUZATRELVIR alone and also in combination with remdesivir, with matching placebo groups for comparison.[2] The trial is designed to compare clinical and virological responses in severely immunocompromised adults with COVID-19.[2]

Key points for patients

These trials are focused on people with COVID-19 who may have a greater risk of serious outcomes.[1][2] The studies are not about routine care; they are research studies that aim to see whether IBUZATRELVIR can improve important health outcomes in specific patient groups.[1][2]

Because the studies are Phase 3, they are looking at how well the treatment works in larger groups and how it compares with placebo or another treatment strategy.[1][2] The results are meant to help show whether the study medicine can reduce worsening illness, hospital-level care, and ongoing infection.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT06679140 Phase 3 COVID-19 in nonhospitalized adults and adolescents at high risk for severe disease Authorised 2330
2024-517671-21-00 Phase 3 COVID-19 in adults with a severely compromised immune system Authorised 300

FAQ

  • Who can take part in IBUZATRELVIR clinical trials? The trials include adults and adolescents with COVID-19 who are not hospitalized but are at risk for severe disease, and adults with COVID-19 who are severely immunocompromised. Each study has its own entry rules.
  • What are the IBUZATRELVIR trials trying to find out? They are checking whether IBUZATRELVIR can reduce worsening illness, emergency department visits, hospitalization, and death. One study also looks at whether it helps with recurrent or persistent SARS-CoV-2 infection.
  • What phase are the IBUZATRELVIR trials? Both trials listed are Phase 3 studies. Phase 3 trials usually compare a study medicine with placebo or another treatment in a larger group of participants.
  • What conditions are being studied? The trials are focused on coronavirus disease 2019, also called COVID-19. One study is in people at high risk of progression to severe illness, and the other is in people with a severely compromised immune system.
  • What outcomes are measured in these trials? The studies measure outcomes such as emergency department visits with treatment, hospitalization, death, and signs of ongoing SARS-CoV-2 infection. These outcomes help show whether the study treatment improves clinical and virological responses.

Ongoing Clinical Trials on IBUZATRELVIR

  • Study of ibuzatrelvir alone or combined with remdesivir in adults with COVID-19 who have severely compromised immune systems

    Recruiting

    3 1
    Investigated drugs:
    Belgium Denmark France Germany Greece The Netherlands +3

  • Study of ibuzatrelvir tablets in non-hospitalized adults and adolescents with COVID-19 who are at high risk of developing severe illness

    Recruiting

    3 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark Finland Germany +2

Glossary

  • COVID-19: Coronavirus disease 2019, an illness caused by the SARS-CoV-2 virus.
  • SARS-CoV-2: The virus that causes COVID-19.
  • Nonhospitalized: Not staying in the hospital at the time of the study.
  • High risk of severe disease: A higher chance that the illness could become serious.
  • Severely immunocompromised: Having a very weak immune system, so the body may not fight infection well.
  • Phase 3: A later stage of clinical research that tests a treatment in larger groups and compares it with placebo or another treatment.
  • Placebo: An inactive treatment used for comparison in a trial.
  • Interventional study: A study where researchers give a treatment and measure the results.
  • Primary outcome: The main result the study is designed to measure.
  • Composite endpoint: A main result that combines several events into one outcome measure.
  • Emergency department visit: A hospital visit for urgent medical care.
  • Virological response: A change in the virus in the body, such as whether the infection is still present.

References