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VOXVOGANAN

Clinical trials are investigating VOXVOGANAN in people with COVID-19 and COVID-like illness in primary care. These studies aim to evaluate recovery time, viral clearance, and other measures of illness severity. The trial is a phase 4 interventional study with a large target population.

Table of contents

Clinical trials overview

The available trial for VOXVOGANAN is an interventional study, which means researchers give a study treatment or comparison product and then measure the results.[1] It is studying people with COVID-19 and COVID-like illness in primary care.[1]

The study status is Authorised, and the planned enrollment is 1201 people.[1] The trial title shows that it is focused on treatment in the primary care setting.[1]

Who is being studied

The target population is people with COVID-19 or COVID-like illness.[1] The source data do not list the full inclusion or exclusion rules, so the exact participation criteria are not available here.[1]

The study is set in primary care, which usually means routine first-contact health care rather than hospital care.[1] This suggests the trial is looking at people who are being managed outside the hospital.[1]

Study design and phase

This is a Phase 4 trial.[1] Phase 4 studies are later-stage trials that look at a treatment in a broader real-world type setting after earlier research has already happened.

The brief summary says the platform study is phase dependent, meaning the main goal can change depending on the part of the study or intervention-specific appendix.[1] For the main protocol, the trial aims to compare the study product with usual care or with a comparator such as placebo.[1]

What the trials measure

One main outcome is the time to first self-report of feeling recovered from symptoms related to COVID-19 or COVID-like illness.[1] This means the study asks when a person first says they feel recovered.

The trial also measures viral clearance, which means whether the virus is gone or much lower in the body, and may also measure viral load, which is the amount of virus present.[1] In addition, the study may look at biomarkers, which are body measurements that can show illness severity or immune response.[1]

For one part of the study, called ISA D, the primary objective is viral clearance by VOXVOGANAN measured at Day 3 after inclusion compared with placebo.[1] The source data also mention a phase IIa-type evaluation for viral clearance, viral load, and biomarkers, and a phase IIb/III-type evaluation for time to recovery.[1]

Study comparators and treatment groups

The trial compares the study treatment with usual care or with a comparator, such as placebo or another study product.[1] A placebo is a look-alike product without the active substance, used to make the comparison fair.

The intervention list includes VOXVOGANAN, nitric oxide nasal spray, saline nasal spray, and placebo nasal sprays.[1] The source data do not explain the full role of each product in this summary, but they show that different nasal spray options are part of the platform study.[1]

What the data do not say

The source data do not provide detailed participant rules, such as age limits, lab requirements, or symptom duration.[1] They also do not give detailed results, so this article focuses on the study goals and design rather than outcomes.[1]

The data available here describe one authorised trial and its main endpoints, but they do not include a full list of all related studies.[1]

Trial ID Phase Condition studied Status Enrollment
2022-501707-27-01 Phase 4 COVID-19, COVID-like illness Authorised 1201

FAQ

  • What are clinical trials of VOXVOGANAN studying? They are studying VOXVOGANAN in people with COVID-19 and COVID-like illness. The main goals are to see how quickly symptoms improve and whether the virus clears from the body.
  • Who may take part in these trials? The trial data show that the target group is people with COVID-19 or COVID-like illness in primary care. The exact entry rules are not listed in the source data.
  • What phase is the VOXVOGANAN trial? The study is a phase 4 trial. This means it is being studied in a later stage of clinical research, after earlier testing has already been done.
  • What results are the trials measuring? The trials measure time to first feeling recovered, viral clearance, viral load, and some markers of illness severity or immune response. One part of the study also looks at viral clearance on Day 3 compared with placebo.
  • How many people are planned for the study? The enrollment is 1201 people. That means the study plans to include 1201 participants.

Ongoing Clinical Trials on VOXVOGANAN

  • Study on Nitric Oxide and Saline Nasal Sprays for Treating COVID-19 and Similar Illnesses in Primary Care Patients

    Not recruiting

    4 1
    Investigated drugs:
    Belgium France Germany Ireland Poland Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment works and how well it performs.
  • Interventional study: A study where participants receive a treatment or comparison product so researchers can measure the effect.
  • Phase 4: A later stage of clinical research that studies a treatment in a larger group of people.
  • Primary care: Basic health care, often the first place people go when they feel sick.
  • COVID-like illness: Illness with symptoms that look like COVID-19, even if the cause is not yet fully confirmed.
  • Viral clearance: When the virus is no longer found, or is found at much lower levels, in the body.
  • Viral load: The amount of virus in a sample from the body.
  • Biomarkers: Measured signs in the body that can help show how severe an illness is or how the body is responding.
  • Comparator: A treatment or placebo used for comparison in a trial.
  • Placebo: A look-alike product with no active substance, used to compare results fairly.
  • Enrollment: The planned number of people who will join a study.

References

  1. https://clinicaltrials.gov/study/2022-501707-27-01