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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline up to Day2-7 and Day14 |
| The correlation between viral load and bronchiolitis score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lanjuan li | Shulan (Hangzhou) Hospital | Principal Investigator |
| Zhen Qin | Shulan (Hangzhou) Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated hospital of Bengbu Medical University | Bengbu | Anhui | China | |||
| Chongqing University Jiangjin Hospital |
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| 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. |
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| 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 |
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 |
| Chongqing |
| Chongqing Municipality |
| China |
| Xiamen Children's Hospital | Xiamen | Fujian | 361006 | 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 | 518106 | China |
| Liuzhou People's Hospital | Liuzhou | Guangxi | 545006 | China |
| Hainan women and children's Medical centre | Haikou | Hainan | China |
| Sanmenxia Central Hospital | Sanmenxia | Henan | China |
| Changde First people's Hospital | Changde | Hunan | China |
| Hunan Provincial Maternal and Child Health Care Hospital | Changsha | Hunan | China |
| Children's Hospital of Soochow University | Suzhou | Jiangsu | 215003 | China |
| Jiangxi Maternal and Child Health | Nanchang | Jiangxi | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | China |
| Linfen Central Hospital | Linfen | Shanxi | 041000 | China |
| Mianyang Central Hospital | Mianyang | Sichuan | China |
| Shulan (hangzhou) Hosipital | Hangzhou | Zhejiang | 310022 | China |
| Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Hangzhou First people's Hospital | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| C000722705 | GS-621763 |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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