Clinical trial NCT06206720: A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infection
Lead sponsor: Vigonvita Life Sciences
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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，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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events during the study
timeFrame: From baseline through study completion, up to Day 26
measure: Subject withdrawals due to Adverse Events
timeFrame: From baseline through study completion, up to Day 26
measure: Time to resolution of 6 clinical symptoms related to RSV infection
timeFrame: From baseline through study completion, up to Day 14
measure: Time to resolution of individual clinical symptoms related to RSV infection
timeFrame: From baseline through study completion, up to Day 14
measure: Differences of the proportion of subjects with wheezing remission
timeFrame: From baseline up to Day2-7 and Day14
measure: Differences of the proportion of subjects with wheezing resolution
timeFrame: From baseline up to Day2-7 and Day14
measure: Difference of the proportion of subjects with cough remission
timeFrame: From baseline up to Day2-7 and Day14
measure: Difference of the proportion of subjects with cough resolution
timeFrame: From baseline up to Day2-7、Day14 and D26
measure: Changes of bronchiolitis score
timeFrame: From baseline up to Day2-7 and Day14
measure: Proportions of subjects achieving symptom remission &disease remission
timeFrame: From baseline up to Day2-7 and Day14
measure: Time from first treatment to symptom remission &disease remission
timeFrame: From first treatment through study completion, up to Day 14
measure: Differences of frequency of Intensive Care Unit (ICU) admission
timeFrame: From first treatment through study completion, up to Day 14
measure: Differences of length of ICU stay
timeFrame: From first treatment through study completion, up to Day 14
measure: Differences of frequency of assisting ventilation
timeFrame: From first treatment through study completion, up to Day 14
measure: Differences in the duration of receiving oxygen therapy
timeFrame: From first treatment through study completion, up to Day 14
measure: Changes of viral load
timeFrame: From baseline up to Day2-7 and Day14
measure: Changes of area under curve of viral load
timeFrame: From baseline up to Day2-7 and Day14
measure: Apparent total body clearance (CL/F)
timeFrame: From baseline up to Day2-7
measure: Area under the plasma concentration time curve from time zero to the last(AUC0-t)
timeFrame: From baseline up to Day2-7
measure: apparent volume of distribution(V)
timeFrame: From baseline up to Day2-7
Secondary outcomes:
measure: The correlation between viral load and the resolution time of 6 clinical signs related to RSV infection
timeFrame: From baseline up to Day2-7 and Day14
measure: The correlation between viral load and bronchiolitis score
timeFrame: From baseline up to Day2-7and Day14
measure: 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
timeFrame: From baseline up to Day2-7 and Day14
measure: The difference in length of hospital stay
timeFrame: From baseline up to Day2-7 and Day14
measure: Proportions of subjects with viral load below LLOQ
timeFrame: From baseline up to Day2-7 and Day14
measure: 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
timeFrame: From baseline up to Day2-7 and Day14
measure: 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
timeFrame: From baseline up to Day2-7 and Day14
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The first Affiliated hospital of Bengbu Medical University
state: Anhui
city: Chongqing
country: China
facility: Chongqing University Jiangjin Hospital
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Children's Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiamen Maternity and Child Healthcare Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Women and Children's Hospital and Health Institute
state: Guangdong
city: Guangzhou
country: China
facility: Panyu Maternal and Child care Service centre of Guangzhou
state: Guangdong
city: Shantou
country: China
facility: The Sceond Affiliated hospital of Shantou University Medical college
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Guangming District People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Haikou
country: China
facility: Hainan women and children's Medical centre
state: Hainan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Changde
country: China
facility: Changde First people's Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Shulan (hangzhou) Hosipital
state: Zhejiang
city: Hangzhou
country: China
facility: Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First people's Hospital
state: Zhejiang
Study officials:
affiliation: Shulan (Hangzhou) Hospital
name: lanjuan li
role: PRINCIPAL_INVESTIGATOR
affiliation: Shulan (Hangzhou) Hospital
name: Zhen Qin
role: PRINCIPAL_INVESTIGATOR
References: