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Zelicapavir

Zelicapavir clinical trials are studying whether this investigational treatment can help adults with respiratory syncytial virus (RSV) infection. The trial data focus on safety and how well the treatment works in non-hospitalized adults who are at high risk for complications.

Table of Contents

Trial overview

The available trial for Zelicapavir studied adults with acute respiratory syncytial virus (RSV) infection who were not in the hospital and who were at high risk for complications.[1] It was a Phase 2, interventional study, which means researchers gave a study treatment and watched what happened over time.[1]

The study was completed and enrolled 111 people.[1]

Who was studied

The trial focused on non-hospitalized adults, meaning participants were able to stay out of the hospital while taking part.[1] The group was also described as being at high risk for complications, which means they had a greater chance of getting sicker from RSV.[1]

The condition under study was respiratory syncytial virus (RSV), a breathing infection that can affect the lower airways and lungs.[1]

What was measured

The main outcome was the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms through Day 33.[1] “Resolution” means the symptoms improved or went away.[1]

The symptoms measured were cough, shortness of breath, wheezing, and coughing up phlegm, also called sputum.[1] Researchers used the Respiratory Infection Intensity and Impact Questionnaire, or RiiQ™ symptom scale, to track these symptoms.[1]

Trial design and phase

This was a Phase 2 study, which is a stage that usually looks more closely at whether a treatment may work while continuing to check safety.[1] The trial compared Zelicapavir with placebo, an inactive tablet used as a comparison in research.[1]

The brief study summary said the goal was to evaluate the effect of Zelicapavir compared with placebo on the progression of RSV infection by measuring clinical symptoms.[1]

What the trial helps answer

This trial helps show whether Zelicapavir may shorten the time it takes for RSV symptoms in the lower respiratory tract to improve in high-risk adults who do not need hospital care.[1] It also adds information about safety in this patient group, since the trial was designed to study both effect and safety.[1]

Because only one completed trial is listed in the source data, the current evidence here is limited to this Phase 2 study in adults with RSV.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-513861-38-00Phase 2Respiratory syncytial virus (RSV)Completed111

FAQ

  • What is being studied in Zelicapavir clinical trials? The trial is studying whether Zelicapavir can help adults with acute RSV infection. It compares the study drug with placebo, which is an inactive tablet.
  • Who can join the trial? The study is for non-hospitalized adults with acute RSV infection who are at high risk for complications. The trial data do not give more detailed eligibility rules.
  • What phase is the Zelicapavir trial? The trial is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and continue to check safety.
  • What condition is the trial focused on? The trial focuses on respiratory syncytial virus, also called RSV. RSV can cause lower respiratory tract disease, which means illness in the airways and lungs.
  • What outcome is the study measuring? The main outcome is the time until RSV lower respiratory tract symptoms get better. Symptoms include cough, shortness of breath, wheezing, and coughing up phlegm.

Ongoing Clinical Trials on Zelicapavir

  • Study on the Effectiveness and Safety of EDP-938 for Adults with High-Risk Respiratory Syncytial Virus (RSV) Infection

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia The Netherlands Poland Slovakia Spain

Glossary

  • Respiratory syncytial virus (RSV): A virus that can cause breathing illness, especially in the airways and lungs.
  • Acute infection: A sudden illness that starts quickly and is active now, not a long-term condition.
  • Non-hospitalized: Not staying in the hospital while taking part in the study.
  • High risk for complications: A person has a greater chance of getting sicker or having more serious problems from the infection.
  • Placebo: An inactive tablet used for comparison in a study. It does not contain the study drug.
  • Phase 2: A trial stage that looks at whether a treatment may work and keeps checking safety.
  • Interventional study: A study where researchers give a treatment and observe what happens.
  • Lower respiratory tract disease (LRTD): Illness in the lower parts of the breathing system, such as the lungs and smaller airways.
  • Symptoms: Signs of illness that a person feels or notices, such as cough or shortness of breath.
  • Primary outcome: The main result the researchers plan to measure to see if the study treatment works.
  • RiiQ™ symptom scale: A questionnaire used to measure how strong RSV symptoms are and how much they affect daily life.

References

  1. https://clinicaltrials.gov/study/2024-513861-38-00