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SIPAVIBART

Clinical trials are investigating SIPAVIBART for prevention of COVID-19. These studies look at safety and how well it may help stop symptomatic COVID-19 in adults at risk, including people who were SARS-CoV-2 negative at the start. The main trial is a Phase 3 study.

Table of Contents

Trial overview

The clinical trial data for SIPAVIBART describes one main study, called SUPERNOVA, which was designed to look at prevention of COVID-19.[1] It was an interventional study, which means researchers gave a study treatment and then measured the results.[1]

The trial was in Phase 3, which is a later stage of testing in a larger group of people.[1] The study status was completed.[1]

Who was studied

The main study focused on people in a SARS-CoV-2-negative set, meaning they did not have evidence of current SARS-CoV-2 infection at the start of the trial.[1] The source data does not provide more detailed eligibility rules, so the exact full entry criteria are not listed here.[1]

The trial also included a sentinel safety cohort, which is a smaller group used to watch safety closely at the start of treatment.[1]

What the trials measured

The main goal was to evaluate safety and compare how well SIPAVIBART worked in preventing symptomatic COVID-19.[1] The study compared SIPAVIBART with EVUSHELD and/or placebo, depending on the cohort and study setup.[1]

One key outcome was the occurrence of adverse events, including serious adverse events, medically attended adverse events, and adverse events of special interest.[1] These were collected during the study and for about 90 days after each study treatment dose in the main cohort, and during the study in the sentinel safety cohort.[1]

Another main outcome was the first confirmed symptomatic COVID-19 case, measured from the time of the first dose until the participant developed symptoms.[1] Researchers also measured cases caused by matched variants, which the source defines as variants that do not contain the F456L mutation.[1]

Study design and cohorts

The trial had a main cohort and a sentinel safety cohort.[1] The main cohort was used to compare prevention of symptomatic COVID-19 and to assess safety in the larger study group.[1]

The brief summary says the main cohort aimed to evaluate the safety of SIPAVIBART and EVUSHELD and/or placebo, and to compare SIPAVIBART with EVUSHELD and/or placebo for prevention of symptomatic COVID-19 caused by any SARS-CoV-2 variant.[1] It also aimed to compare prevention of symptomatic COVID-19 caused by matched variants.[1]

The sentinel safety cohort was used to evaluate safety with close monitoring.[1] This kind of cohort helps researchers watch for safety issues early and carefully.[1]

Trial status and size

The study enrolled 3,349 participants.[1] That makes it a large Phase 3 trial, which is important for learning more about both safety and preventive effect in a broad study group.[1]

The only trial provided in the source data is NCT05648110, so the article summary reflects this single study rather than a larger set of SIPAVIBART trials.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05648110 Phase 3 COVID-19 Completed 3349

FAQ

  • What are clinical trials of SIPAVIBART studying? They are studying whether SIPAVIBART can help prevent symptomatic COVID-19. The trials also measure safety, including side effects reported during the study period.
  • Who can take part in these trials? The main study includes a SARS-CoV-2-negative group, meaning people who did not have evidence of current infection at the start. The source data does not give more detailed entry rules.
  • What phase is the SIPAVIBART trial? The main trial listed is a Phase 3 study. Phase 3 trials usually test a treatment in a larger group to better understand safety and how well it works.
  • What condition is being studied? The condition studied is COVID-19. The trial looks at prevention of symptomatic COVID-19 caused by any SARS-CoV-2 variant and also by matched variants.
  • What results are measured in the trial? The trial measures confirmed symptomatic COVID-19 and safety events such as adverse events, serious adverse events, medically attended adverse events, and events of special interest. These are tracked during the study and for about 90 days after dosing.

Ongoing Clinical Trials on SIPAVIBART

  • Study on COVID-19 Prevention Using Sipavibart and Cilgavimab for Patients with Weakened Immune Systems

    Not recruiting

    3 1 1
    Investigated drugs:
    Belgium Denmark France Germany Poland Spain

Glossary

  • COVID-19: An illness caused by the SARS-CoV-2 virus. In these trials, the focus is on preventing symptoms of the disease.
  • SARS-CoV-2: The virus that causes COVID-19.
  • SARS-CoV-2-negative: A person who does not have evidence of current SARS-CoV-2 infection at the start of the study.
  • Phase 3: A later stage of clinical testing in a larger group of people. It helps researchers learn more about safety and how well a study treatment works.
  • Interventional study: A trial where researchers give a study treatment and then measure what happens.
  • Primary outcome: The main result the researchers want to measure.
  • Confirmed symptomatic COVID-19: COVID-19 that is both confirmed and causes symptoms. This is one of the main results measured in the study.
  • Adverse event (AE): Any health problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event (SAE): A more serious health problem that may need hospital care or cause major harm.
  • Medically attended adverse event (MAAE): A health problem that leads to medical care or a visit to a healthcare professional.
  • Adverse event of special interest (AESI): A side effect or health problem that researchers watch very closely because it may be especially important for the study.
  • Matched variants: Virus variants that fit the study’s definition for comparison. The source says these are variants that do not contain the F456L mutation.

References