A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
- Conditions
- Respiratory Synctial Virus Infections
- Interventions
- Drug: Placebo
- Registration Number
- NCT06775405
- Lead Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Brief Summary
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.
- Detailed Description
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study conducted among Chinese infants aged 1 to 24 months hospitalized with Respiratory Syncytial Virus (RSV) infection.
The study plans to enroll 180 infants aged 1 to 24 months with RSV infection. Eligible subjects will be randomized in a 1:1 ratio (AK0529: placebo). These subjects will receive the study drug twice daily for 5 consecutive days and the dose depends on subject's weight range.
Each subject in this study will undergo a visit schedule comprising a screening period of 36 hours before the first dose, a 5-day double-blinded treatment period, and a 9-day safety follow-up period after the last dose of treatment. The expected duration of participation for each subject will not exceed 17 days.
Infants successfully enrolled in this study will take the medication every 12 hours for 5 consecutive days, in total 10 doses. Investigators will regularly score the infants using the Wang bronchiolitis clinical score which is the primary endpoint. Additionally, nasopharyngeal aspirates samples will be collected from the infants for virological testing before the first dose on Days 1 to 5, on Day 6, and on Day 14.
Safety and tolerability assessments in this study will include evaluations of adverse events (AEs)/serious adverse events (SAEs), vital signs and blood oxygen saturation (SpO2) levels, physical examinations, clinical laboratory tests, and electrocardiogram (ECG) findings.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active drug AK0529 The participants will receive AK0529 of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. Placebo Placebo The participants will receive placebo of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5.
- Primary Outcome Measures
Name Time Method Change from baseline in the Wang bronchiolitis clinical score Day 3 (48 hours) The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
- Secondary Outcome Measures
Name Time Method Change from baseline in the Wang bronchiolitis clinical score in subjects younger than 6 months. Day 3 (48 hours) The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
Time from first treatment to sustained remission of symptoms during the treatment period. Study period (up to 14 days) The sustained remission is defined as achieving a total Wang bronchiolitis clinical score of 0 or 1 for 48 consecutive hours without support of oxygen therapy.
Change in RSV VL (viral load) from baseline at each visit. Day 2, Day 3, Day 4, Day 5, Day 6, Day 14 The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Proportion of subjects with RSV VL below the lower limit of quantitation (LLOQ) at each visit. Day 2, Day 3, Day 4, Day 5, Day 6, Day 14 The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Time from first treatment to mild disease for subjects, defined as achieving a Wang bronchiolitis clinical score ≤ 3 without the need for supplemental oxygen. Study period (up to 14 days) Change in sub-scores of the Wang bronchiolitis clinical score from baseline at each visit. Day 2, Day 3, Day 4, Day 5, Day 6, Day 14 The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
Time from initial dosing to resolution of symptoms based on sub-scores of the Wang bronchiolitis clinical score. Study period (up to 14 days) The resolution is defined as achieving the following sub-scores without the need for supplemental oxygen:
* Respiratory rate = 0 or 1
* Wheezing = 0 or 1
* Respiratory muscle retraction = 0 or 1
* General condition = 0 Note: The above indicators are only for subjects with a baseline sub-score greater than 0 for the respective sub-scores.Safety endpoints Study period (up to 14 days) The safety assessment includes the following events, tests, indicators occurring during the study process:
* Incidence rate and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and withdrawal from the study due to AEs;
* Laboratory tests;
* Electrocardiogram (ECG);
* Physical examination and vital signs.Pharmacokinetic endpoints Study period (up to 14 days) Include but not limit to steady state AUC, Cmax and Ctrough.
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Trial Locations
- Locations (17)
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, China
First Hospital of Jilin University
🇨🇳Changchun, China
Hunan Provincial People's Hospital
🇨🇳Changsha, China
West China Second University Hospital, Sichuan University
🇨🇳Chengdu, China
Children's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Sanya Central Hospital, Hainan Third People's Hospital
🇨🇳Sanya, China
Shanghai Children's Hospital, Shanghai Jiao Tong University
🇨🇳Shanghai, China
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
Tianjin Children's Hospital（Longyan）
🇨🇳Tianjin, China
Tianjin Children's Hospital（Machang）
🇨🇳Tianjin, China
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Wuxi Children's Hospital
🇨🇳Wuxi, China
First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Women and Children's Hospital, and the School of Medicine, Xiamen University
🇨🇳Xiamen, China
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital
🇨🇳Zhongshan, China