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

Respiratory Syncytial Virus Infection Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206720
• Other study ID #: VV116-RSV-II/III-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Vigonvita Life Sciences
• Contact: Huaqing Duan
• Phone: 18061926005
• Email: huaqing.duan[@]vigonvita.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The first Affiliated hospital of Bengbu Medical University	Bengbu	Anhui
China	Changde First people's Hospital	Changde	Hunan
China	Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan
China	Chongqing University Jiangjin Hospital	Chongqing	Chongqing
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	Hainan women and children's Medical centre	Haikou	Hainan
China	Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Hangzhou First people's Hospital	Hangzhou	Zhejiang
China	Shulan (hangzhou) Hosipital	Hangzhou	Zhejiang
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Linfen Central Hospital	Linfen	Shanxi
China	Mianyang Central Hospital	Mianyang	Sichuan
China	Jiangxi Maternal and Child Health	Nanchang	Jiangxi
China	Sanmenxia Central Hospital	Sanmenxia	Henan
China	The Sceond Affiliated hospital of Shantou University Medical college	Shantou	Guangdong
China	Xiamen Maternity and Child Healthcare Hospital	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Vigonvita Life Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Apparent total body clearance (CL/F)	Apparent clearance of of 116-N1.	From baseline up to Day2-7
Primary	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
Primary	apparent volume of distribution(V)	Apparent volume of distribution during the terminal phase of 116-N1.	From baseline up to Day2-7
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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