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

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 hourspreceding 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 expectedto be hospitalized;

7. The parent/legal guardian must have provided written informed consent for thepatient to participate.

Exclusion Criteria:

1. Patients who are less than 12 months old and whose head circumference is not withinthe 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, mycoplasmainfection or bacterial infection；

5. Patients with hypercapnia (Except for patients who have recovered at the time ofscreening);

6. Chronic or persistent feeding difficulties;

7. Concurrent gastrointestinal conditions that could seriously, in the opinion of theinvestigator, prejudice absorption of the Investigational Medicinal Product;

8. Symptomatic because of inborn errors of metabolism;

9. Bronchopulmonary dysplasia requiring assisted ventilationor with clinicallysignificant congenital respiratory abnormalities, except for the result of RSVinfection;

10. Patients with congenital heart disease (CHD) with significant hemodynamic changes,except simple CHD (such as patent ductus arteriosus, atrial septal defect orventricular septal defect without hemodynamic influence).

11. Clinical evidence of hepatic decompensation

12. Renal failure including renal anomalies likely to be associated with renalinsufficiency;

13. Patient is known to be HIV-positive (or the mother, if the potential patient is achild 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, orrenal disease unrelated to RSV infection at baseline or any other medical conditionthat in the opinion of the investigator renders the patient unsuitable forenrollment;

18. Participation in an investigational drug or device study within 30 days prior to thedate of screening;

19. Failure to satisfy the investigator of fitness to participate for any other reason.