A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-24
SponsorShanghai Ark Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing.
The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing.
Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards.
Disqualifiers
The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours.
Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment .
Subject is known to have bacterial pneumonia.
Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy).
Trial design
Design model
Parallel
Treatments tested in this trial
AK0529
DrugActive Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Placebo
DrugActive Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Active drugExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Wang bronchiolitis clinical score
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 frame
Day 3 (48 hours)Secondary outcomes
1
Change from baseline in the Wang bronchiolitis clinical score in subjects younger than 6 months.
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 frame
Day 3 (48 hours)2
Time from first treatment to sustained remission of symptoms during the treatment period.
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.
Time frame
Study period (up to 14 days)3
Change in RSV VL (viral load) from baseline at each visit.
The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Time frame
Day 2, Day 3, Day 4, Day 5, Day 6, Day 144
Proportion of subjects with RSV VL below the lower limit of quantitation (LLOQ) at each visit.
The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Time frame
Day 2, Day 3, Day 4, Day 5, Day 6, Day 14Sponsors and contacts
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Source ClinicalTrials.gov