Respiratory Syncytial Virus Infection
Conditions
Interventions
Low-dose Investigational drug group:Low-dose Deuremidevir Hydrobromide for Suspension+standard treatment Intervention
Middle-dose Investigational drug group:Middle-dose Deuremidevir Hydrobromide for Suspension+standard treatment Intervention
High-dose Investigational drug group:High-dose Deuremidevir Hydrobromide for Suspension+standard treatment Intervention
Placebo group:Placebo+standard treatment Intervention
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: (1) Male or female infants =1 month and =24 months (born after =37 weeks of gestation); (2) Diagnosis of RSV infection by antigen detection 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
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 or cautiously 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events during the study;Subject withdrawals due to Adverse Events;Changes of bronchiolitis score;Proportions of subjects achieving symptom remission &disease remission;Time from first treatment to symptom remission &disease remission;Differences of frequency of Intensive Care Unit (ICU) admission and length of ICU stay;Differences of frequency of assisting ventilation therapy;Differences in the duration of receiving oxygen therapy;Changes of viral load;Changes of area under curve of viral load;Apparent total body clearance (CL);Area under the plasma concentration time curve from time zero to the last(AUC0-t);apparent volume of distribution(V); | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between viral load and bronchiolitis score;The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (change in bronchiolitis score from baseline) in subjects;The difference in length of hospital stay;Proportions of subjects with viral load below LLOQ;The correlation between PK parameters and bronchiolitis score and RSV viral load (VL) in respiratory sample; | — |
Countries
China
Contacts
Public ContactLanjuan Li
Shulan (Hangzhou) Hospital
Outcome results
None listed