A Study of AK0529 in Chinese Infants Hospitalized With RSV | NCT04231968

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AK0529	Experimental	Participants who are randomized to the experimental arm will receive AK0529 twice daily for five days .	Drug: AK0529
Placebo	Placebo Comparator	Participants in the control arm will be administered placebo at the matching dosage levels of active medications.	Drug: Matching placebo of AK0529

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AK0529	Drug	AK0529 capsule will be orally administered at the twice-daily dosing levels of 10 mg, 20 mg, or 40 mg for five days based on the patient's weight.	AK0529

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinically significant change from baseline in bronchiolitis score on Day 3	To demonstrate that AK0529 is superior to placebo in terms of changes from baseline in bronchiolitis signs and symptoms score. The differences of change in the bronchiolitis score are to be evaluated between the AK0529 and placebo arms after treatment. The total score is reported with a range from 0 to 12. Generally, each score component has a range of values from 0 to 3. A decreasing value of the total score represents a clinical improvement. Unless otherwise noted, the last non-missing measurement/assessment before the first dose of the investigational product is defined as the Baseline measurement. If a measurement/evaluation is performed on the same day of the first dose of the investigational product, these measurements will be considered as Baselines.	From Baseline (Pre-dose on Day 1) to Day 3 (48 hours)

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in RSV (Respiratory syncytial virus) VL(viral load ) on Day 5	To evaluate the antiviral effects of AK0529. 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 AK0529 and placebo arms after treatment.	From Baseline (Pre-dose on Day 1) to Day 5 (96 hours)

Other Outcomes

Measure	Description	Time Frame
RSV VL and primary and selected secondary efficacy measurements	To evaluate the relationship of antiviral effects of AK0529 to the primary and key secondary efficacy measurements.	From Baseline to Day 14
Selective primary efficacy, secondary efficacy, and safety measures for the pharmacokinetic-pharmacodynamic (PK-PD) analysis

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Male or female patients of any ethnicity with an age-adjusted for any prematurity of ≥1 month and ≤24 months.
Diagnosis of RSV infection by any virological means within 36 hours preceding the initial dose.
The time from the onset caused by RSV infection to the first dose should be ≤ 7 days. Time of onset is defined as the time the first respiratory or systemic signs or symptoms of RSV infection confirmed by the investigator.
Body weight ≥ 2.5 kg and ≤ 20 kg at screening.
For patients aged <12 months, an occipitofrontal head circumference should be within the normal range for age and gender.
Bronchiolitis score ≥ 5.
The parent/legal guardian must have provided written informed consent for the patient to participate.

Main Exclusion Criteria:

Patients who have used any prohibited medications within 72 hours prior to expected administration and those who have used inhaled or systemic glucocorticosteroids within 24 hours prior to administration.
Patients (or mothers of patients younger than 6 months of age) with a known HIV-positive history or patients highly suspected HIV-positive by the investigator.
Patients with known co-infection with influenza virus.
Patient known to have pneumonia caused by bacterial infection.
Patients requiring vasopressors or vasoactive drugs at the time of enrollment.
Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product.
Bronchopulmonary dysplasia requiring assisted ventilation at the time of enrolment, except for the result of RSV infection.
Patients at risk for hypercapnia based on their medical history, except for the result of RSV infection.
Patient with airway malformations and congenital heart diseases, except for isolated patent ductus arteriosus and/or patent foramen ovale.
Renal failure including renal abnormalities likely to be associated with renal insufficiency.
Clinical evidence of hepatic decompensation.
Symptomatic because of congenital metabolic abnormality.
Chronic or persistent feeding difficulties.
Known or suspected to have primary immunodeficiency disease.
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 enrolment; in case of any question, discuss such cases with the sponsor's medical monitor.
A history of epilepsy or seizures including febrile seizures.
History of family history of high allergies or allergies to multiple substances, or presence of severe rash that in the opinion or the investigator renders the patient unsuitable for enrollment.
The patient's parent or guardian is an employee of the investigator or the study site with direct involvement in the proposed study or other studies under the direction of that investigator of the study site, or any family members of the employees or the investigator.
Participation in an investigational drug or device study within 30 days prior to the date of screening.
Failure to satisfy the investigator of fitness to participate for any other reason.

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Children's Hospital		Beijing		100045	China
Peking University Third Hospital

PubMed Identifier	Type	Citation	Retractions
40246359	Derived	Zhang H, Zhao W, Zhang X, Zhang L, Guo R, Huang H, Lin L, Liu F, Chen H, Shen F, Wu J, Huang X, Zhu X, Li F, Zou G, Chien J, Humphries M, Lu Q, Wu JZ, Zhao S, Liu H, Ni X; AIRFLO Study Group. Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up. Lancet Child Adolesc Health. 2025 May;9(5):325-336. doi: 10.1016/S2352-4642(25)00067-7.
39321361

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections