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

A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus Infection
• Intervention / Treatment: Drug: Deuremidevir Hydrobromide for Suspension; Drug: Placebo

Detailed Description

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), middle-dose group (30 mg/kg) and high-dose group (50 mg/kg), 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
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Huaqing Duan; Phone Number: 18061926005; Email: huaqing.duan@vigonvita.cn

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical University
      • Contact: Rui Zhou
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Chongqing University Jiangjin Hospital
      • Contact: Hong Fu
  • Fujian
    • Xiamen, Fujian, China
      • Not yet recruiting
      • Xiamen Maternity and Child Healthcare Hospital
      • Contact: Tong Shen
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong women and children's hospital and health institute
      • Contact: Zengqing Li
    • Guangzhou, Guangdong, China
      • Recruiting
      • Panyu Maternal and Child care Service centre of Guangzhou
      • Contact: Qiuying Peng
    • Shantou, Guangdong, China
      • Recruiting
      • The Sceond Affiliated hospital of Shantou University Medical college
      • Contact: chuangxin lin
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan women and children's Medical centre
      • Contact: Wei Xiang
  • Henan
    • Sanmenxia, Henan, China
      • Recruiting
      • Sanmenxia Central Hospital
      • Contact: Chunying Ma
  • Hunan
    • Changde, Hunan, China
      • Recruiting
      • Changde First people's Hospital
      • Contact: Minghui Wang
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial Maternal and Child Health Care Hospital
      • Contact: Xiangfeng Yang
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Maternal and Child Health
      • Contact: Qingxiong Zhu
  • Shandong
    • Liaocheng, Shandong, China
      • Recruiting
      • Liaocheng People's Hospital
      • Contact: Aihua cui
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Recruiting
      • Linfen Central Hospital
      • Contact: jiangli xi
  • Sichuan
    • Mianyang, Sichuan, China
      • Recruiting
      • Mianyang Central Hospital
      • Contact: Yan Li
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Hangzhou First People's Hospital
      • Contact: Chunming Jiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Children's Hospital of Zhejiang University School of Medicine
      • Contact: zhimin chen
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Shulan (hangzhou) Hosipital
      • Contact: lanjuan li; Phone Number: （0571）-56097873; Email: ljli@zju.edu.cn
      • Contact: Zhen Qin; Phone Number: 18967168520; Email: zqin339@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deuremidevir Hydrobromide for Suspension; Deuremidevir Hydrobromide for Suspension will be orally administered at the twice-daily dosing levels of 15 mg/kg, 30 mg/kg, or 50 mg/kg for five days according to the weight of patients.	Drug: Deuremidevir Hydrobromide for Suspension; 15 mg/kg group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, 10 times. 30 mg/kg group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, 10 times. 50 mg/kg group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, 10 times.; Other Names: VV116
Experimental: Placebo; Placebo will be orally administered at the twice-daily dosing levels of 15 mg/kg, 30 mg/kg, or 50 mg/kg for five days according to the weight of patients.	Drug: Placebo; 15 mg/kg group: 5 subjects will receive placebo once every 12 hours, 10 times. 30 mg/kg group: 5 subjects will receive placebo once every 12 hours, 10 times. 50 mg/kg group: 5 subjects will receive placebo once every 12 hours, 10 times.; Other Names: VV116 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of area under curve of viral load	The antiviral effects are to be determined by measuring the differences in area under curve (AUC).	From baseline up to Day2-6 and Day14
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.	From baseline through study completion, up to Day 26
Subject withdrawals due to Adverse Events	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.	From baseline through study completion, up to Day 26
Time to resolution of 6 clinical symptoms (retraction sign, oxygen desaturation, fever, feeding problems, general condition, tachypnea) related to RSV infection	Time to resolution of 6 clinical symptoms (retraction sign, oxygen desaturation, fever, feeding problems, general condition, tachypnea) related to RSV infection	From baseline through study completion, up to Day 14
Time to resolution of individual clinical symptoms (including retraction sign, oxygen desaturation, fever, feeding problems, general condition, tachypnea) related to RSV infection	Time to resolution of individual clinical symptoms (including retraction sign, oxygen desaturation, fever, feeding problems, general condition, tachypnea) related to RSV infection	From baseline through study completion, up to Day 14
Differences of the proportion of subjects with wheezing remission	Differences of the proportion of subjects with wheezing remission	From baseline up to Day2-7 and Day14
Differences of the proportion of subjects with wheezing resolution	Differences of the proportion of subjects with wheezing resolution	From baseline up to Day2-7 and Day14
Difference of the proportion of subjects with cough remission	Difference of the proportion of subjects with cough remission	From baseline up to Day2-7 and Day14
Difference of the proportion of subjects with cough resolution	Difference of the proportion of subjects with cough resolution	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.	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.	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.	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.	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.	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.	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.	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.	From baseline up to Day2-7 and Day14
Apparent total body clearance (CL/F)	Apparent clearance of of 116-N1.	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.	From baseline up to Day2-7
apparent volume of distribution(V)	Apparent volume of distribution during the terminal phase of 116-N1.	From baseline up to Day2-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between viral load and the resolution time of 6 clinical signs related to RSV infection (retraction sign, oxygen desaturation, fever, feeding problems, general condition, tachypnea)	Check if there is a positive correlation between viral load and the resolution time of 6 clinical signs	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.	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.	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.	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.	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	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	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.	From baseline up to Day2-7 and Day14

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: lanjuan li, Shulan (Hangzhou) Hospital; Principal Investigator: Zhen Qin, Shulan (Hangzhou) Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: VV116-RSV-II/III-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No