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

Phase 2CompletedNCT06206720

Vigonvita Life Sciences60 enrolled

Overview

To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.

This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months. It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Respiratory Syncytial Virus Infection

Interventions

Deuremidevir Hydrobromide for SuspensionDRUG

15 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg TID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension 3 times every day, total 15 times.

PlaceboDRUG

15 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg TID group: 5 subjects will receive placebo 3 times every day, total 15 times.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (22)

The first Affiliated hospital of Bengbu Medical University

Bengbu, Anhui, China

Outcomes

Primary Outcomes

Incidence of Adverse Events during the study

An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Time frame: From baseline through study completion, up to Day 26

Subject withdrawals due to Adverse Events

Time frame: From baseline through study completion, up to Day 26

Time to resolution of 6 clinical symptoms related to RSV infection

Time frame: From baseline through study completion, up to Day 14

Time to resolution of individual clinical symptoms related to RSV infection

Time frame: From baseline through study completion, up to Day 14

Differences of the proportion of subjects with wheezing remission

Time frame: From baseline up to Day2-7 and Day14

Differences of the proportion of subjects with wheezing resolution

Time frame: From baseline up to Day2-7 and Day14

Difference of the proportion of subjects with cough remission

Data from ClinicalTrials.gov

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Chongqing University Jiangjin Hospital

Chongqing, Chongqing Municipality, China

Xiamen Children's Hospital

Xiamen, Fujian, China

Xiamen Maternity and Child Healthcare Hospital

Xiamen, Fujian, China

Guangdong Women and Children's Hospital and Health Institute

Guangzhou, Guangdong, China

Panyu Maternal and Child care Service centre of Guangzhou

Guangzhou, Guangdong, China

The Sceond Affiliated hospital of Shantou University Medical college

Shantou, Guangdong, China

Shenzhen Guangming District People's Hospital

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuchow, Guangxi, China

Hainan women and children's Medical centre

Haikou, Hainan, China

...and 12 more locations

Time frame: From baseline up to Day2-7 and Day14

Difference of the proportion of subjects with cough resolution

Time frame: From baseline up to Day2-7、Day14 and D26

Changes of bronchiolitis score

The differences of change in the bronchiolitis score are to be evaluated between the Deuterium Hydrobromide for suspension and placebo arms after treatment. The total score is reported with a range from 0 to 12. The minimum and maximum values of 0 and 3 separately are defined for each scoring item. A decreasing value of the total score represents a clinical improvement. Subscales are not applicable in this scoring system.

Time frame: From baseline up to Day2-7 and Day14

Proportions of subjects achieving symptom remission &disease remission

Symptom remission was defined as bronchiolitis score ≤1. Disease remission was defined as bronchiolitis score ≤1 and with no assisted ventilation.

Time frame: From baseline up to Day2-7 and Day14

Time from first treatment to symptom remission &disease remission

The time difference from the first treatment to the time subjects achieved symptom remission between the Deuterium Hydrobromide for suspension and placebo arms. The time difference from the first treatment to the time subjects achieved disease remission between the Deuterium Hydrobromide for suspension and placebo arms.

Time frame: From first treatment through study completion, up to Day 14

Differences of frequency of Intensive Care Unit (ICU) admission

The differences of frequency of ICU admission between Deuterium Hydrobromide for suspension and placebo arms.

Time frame: From first treatment through study completion, up to Day 14

Differences of length of ICU stay

The differences of length of ICU stay between Deuterium Hydrobromide for suspension and placebo arms.

Time frame: From first treatment through study completion, up to Day 14

Differences of frequency of assisting ventilation

The frequency difference from the first treatment to the end of assisting ventilation therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.

Time frame: From first treatment through study completion, up to Day 14

Differences in the duration of receiving oxygen therapy

The duration difference from the first treatment to the end of receiving oxygen therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.

Time frame: From first treatment through study completion, up to Day 14

Changes of viral load

The antiviral effects in infants hospitalized with RSV are to be determined by measuring the differences in viral load determined by RT-PCR between the Deuterium Hydrobromide for suspension and placebo arms after treatment.

Time frame: From baseline up to Day2-7 and Day14

Changes of area under curve of viral load

The antiviral effects are to be determined by measuring the differences in area under curve (AUC).

Time frame: From baseline up to Day2-7 and Day14

Apparent total body clearance (CL/F)

Apparent clearance of of 116-N1.

Time frame: From baseline up to Day2-7

Area under the plasma concentration time curve from time zero to the last(AUC0-t)

Area under the plasma concentration time curve from time zero to the last of 116-N1.

Time frame: From baseline up to Day2-7

apparent volume of distribution(V)

Apparent volume of distribution during the terminal phase of 116-N1.

Time frame: From baseline up to Day2-7

Secondary Outcomes

The correlation between viral load and the resolution time of 6 clinical signs related to RSV infection

Check if there is a positive correlation between viral load and the resolution time of 6 clinical signs

Time frame: From baseline up to Day2-7 and Day14

The correlation between viral load and bronchiolitis score

Check if there is a positive correlation between changes in viral load and changes in bronchiolitis score.

Time frame: From baseline up to Day2-7and Day14

The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects

The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects.

Time frame: From baseline up to Day2-7 and Day14

The difference in length of hospital stay

The difference in length of hospital stay between the experimental drug group and the placebo group due to RSV infection related diseases.

Time frame: From baseline up to Day2-7 and Day14

Proportions of subjects with viral load below LLOQ

The proportion of subjects whose viral load values are below LLOQ (lower limit of quantitation) after treatment.

Time frame: From baseline up to Day2-7 and Day14

The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and the resolution time of clinical signs

Time frame: From baseline up to Day2-7 and Day14

The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and bronchiolitis score and RSV viral load (VL) in respiratory sample

The correlation between AUC0-t（ Area under the plasma concentration time curve from time zero to the last） and bronchiolitis score and RSV viral load (VL) in respiratory sample.

Time frame: From baseline up to Day2-7 and Day14