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

NCT06206720 | Completed Phase 2 DMC

• 1 other identifier: VV116-RSV-II/III-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Respiratory Syncytial Virus Infection

Outcome Measures

Primary Outcomes (20)

• 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 related to RSV infection

  Time to resolution of 6 clinical symptoms related to RSV infection

  From baseline through study completion, up to Day 14

• Time to resolution of individual clinical symptoms related to RSV infection

  Time to resolution of individual clinical symptoms 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

• 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 Day2-7 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 Outcomes (7)

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

  From baseline up to Day2-7 and Day14

• The correlation between viral load and 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

  From baseline up to Day2-7 and Day14

• The difference in length of hospital stay

  From baseline up to Day2-7 and Day14

• Proportions of subjects with viral load below LLOQ

  From baseline up to Day2-7 and Day14

Study Arms (2)

Deuremidevir Hydrobromide for Suspension

EXPERIMENTAL

Deuremidevir Hydrobromide for Suspension will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.

Drug: Deuremidevir Hydrobromide for Suspension

Placebo

EXPERIMENTAL

Placebo will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.

Drug: Placebo

Interventions

Deuremidevir Hydrobromide for Suspension DRUG

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.

Also known as: VV116

Deuremidevir Hydrobromide for Suspension

Placebo DRUG

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.

Also known as: VV116 placebo

Placebo

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female infants ≥1 month and ≤24 months；
• Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；
• Onset of RSV infection symptoms should be ≤ 5 days；
• Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；
• Patient must have a Wang Respiratory Score ≥ 5;
• Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;
• The parent/legal guardian must have provided written informed consent for the patient to participate.

You may not qualify if:

• 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;
• Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.
• Requires vasopressors or inotropic support at the time of enrollment;
• Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；
• Patients with hypercapnia (Except for patients who have recovered at the time of screening);
• Chronic or persistent feeding difficulties;
• Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;
• Symptomatic because of inborn errors of metabolism;
• Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;
• 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).
• Clinical evidence of hepatic decompensation
• Renal failure including renal anomalies likely to be associated with renal insufficiency;
• Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged \<6 months);
• Suspected or known to have congenital acquired immunodeficiency;
• A history of epilepsy or seizures;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (22)

The first Affiliated hospital of Bengbu Medical University

Bengbu, Anhui, China

Location

Chongqing University Jiangjin Hospital

Chongqing, Chongqing Municipality, China

Location

Xiamen Children's Hospital

Xiamen, Fujian, 361006, China

Location

Xiamen Maternity and Child Healthcare Hospital

Xiamen, Fujian, China

Location

Guangdong Women and Children's Hospital and Health Institute

Guangzhou, Guangdong, China

Location

Panyu Maternal and Child care Service centre of Guangzhou

Guangzhou, Guangdong, China

Location

The Sceond Affiliated hospital of Shantou University Medical college

Shantou, Guangdong, China

Location

Shenzhen Guangming District People's Hospital

Shenzhen, Guangdong, 518106, China

Location

Liuzhou People's Hospital

Liuchow, Guangxi, 545006, China

Location

Hainan women and children's Medical centre

Haikou, Hainan, China

Location

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Location

Changde First people's Hospital

Changde, Hunan, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215003, China

Location

Jiangxi Maternal and Child Health

Nanchang, Jiangxi, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041000, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, China

Location

Shulan (hangzhou) Hosipital

Hangzhou, Zhejiang, 310022, China

Location

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Hangzhou First people's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Suspensions; GS-621763

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• lanjuan li

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

• Zhen Qin

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 16, 2024
• Study Start: January 31, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-06

Locations

CN (22)