A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV

Launched by VIGONVITA LIFE SCIENCES · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Deuremidevir Hydrobromide to see how safe and effective it is for treating infants with Respiratory Syncytial Virus (RSV), a common virus that can cause serious respiratory issues in young children. The trial is specifically looking at infants aged 1 month to 2 years who have been diagnosed with RSV, are showing symptoms, and are hospitalized or expected to be hospitalized. To join the study, infants must weigh between 2.5 kg and 20 kg and have a certain score indicating the severity of their respiratory symptoms.

If a child is eligible and their parent or guardian agrees to participate, they will receive different doses of the medication during their hospital stay. The trial aims to learn more about how well the medication works, how the body processes it, and its potential side effects. It's important to know that there are specific health conditions that would prevent a child from participating, such as certain infections or medical issues. This study is a valuable step toward finding better treatments for RSV, which can help improve the health and recovery of affected infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female infants ≥1 month and ≤24 months；
• • 2. Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；
• • 3. Onset of RSV infection symptoms should be ≤ 5 days；
• • 4. Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；
• • 5. Patient must have a Wang Respiratory Score ≥ 5;
• • 6. Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;
• • 7. The parent/legal guardian must have provided written informed consent for the patient to participate.
• Exclusion Criteria:
• • 1. Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;
• • 2. Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.
• • 3. Requires vasopressors or inotropic support at the time of enrollment;
• • 4. Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；
• • 5. Patients with hypercapnia (Except for patients who have recovered at the time of screening);
• • 6. Chronic or persistent feeding difficulties;
• • 7. Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;
• • 8. Symptomatic because of inborn errors of metabolism;
• • 9. Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;
• • 10. Patients with congenital heart disease (CHD) with significant hemodynamic changes, except simple CHD (such as patent ductus arteriosus, atrial septal defect or ventricular septal defect without hemodynamic influence).
• • 11. Clinical evidence of hepatic decompensation
• • 12. Renal failure including renal anomalies likely to be associated with renal insufficiency;
• • 13. Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged \<6 months);
• • 14. Suspected or known to have congenital acquired immunodeficiency;
• • 15. A history of epilepsy or seizures;
• • 16. A history of high allergies;
• • 17. Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment;
• • 18. Participation in an investigational drug or device study within 30 days prior to the date of screening;
• • 19. Failure to satisfy the investigator of fitness to participate for any other reason.