Respiratory Syncytial Virus Infections
Conditions
Keywords
Ziresovir, RSV, Chronic Respiratory Disease, Heart Disease, The Elderly
Brief summary
Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.
Interventions
DRUGZiresovir (AK0529)
Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
DRUGPlacebo
Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Sponsors
Shanghai Ark Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-Blind
Intervention model description
This clinical study is a randomized placebo-controlled parallel multi-center phase 2b/3 trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-85 years (inclusive), regardless of gender. * Diagnosed with RSV infection by antigen or nucleic acid test within 36 hours before first dose. * Have at least one of the following high-risk conditions for RSV infection: Chronic respiratory disease; heart disease; immunocompromised status; other chronic disease; age ≥65 years. * Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of breath), with at least one individual symptom rated as moderate or severe (score 2 or 3 per RiiQ Symptom Scale). * Time from symptom onset (or worsening of pre-existing symptoms) to first dose ≤5 days. (Onset defined as time of first RSV-related symptom/sign confirmed by investigator; pre-existing symptoms are those due to underlying conditions)
Exclusion criteria
* Diagnosed with influenza or COVID-19 infection within 7 days prior to providing informed consent. * Suspected bacterial co-infection. * Received any potentially anti-RSV agents (e.g., ribavirin, long-acting interferon) within 5 half-lives prior to the first study dose, or plans to use such agents during the study. * Received prohibited medications, or plans to use prohibited medications during the study. * Has a severe or unstable gastrointestinal, hepatic, renal, hematologic disorder, or malignancy. * Has a known allergy, hypersensitivity, or intolerance to AK0529 or to any excipients in the AK0529 or placebo formulation. * Female participants with a positive pregnancy test result, or who are breastfeeding. * Refusal to use effective contraception during the trial period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from first dose to resolution of LRTD symptoms | Up to Day 27 | LRTD symptoms (cough, shortness of breath, wheezing, expectoration) are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution rates of LRTD symptoms after treatment | Day 3, Day 6, Day 13, Day 27 | LRTD symptoms (cough, shortness of breath, wheezing, expectoration) are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39. |
| Time from first dose to resolution of upper respiratory, systemic, and total symptoms | Up to Day 27 | Upper respiratory, systemic, and total symptoms are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39. |
| Resolution rate of upper respiratory, systemic, and total symptoms | Day 3, Day 6, Day 13, Day 27 | Upper respiratory, systemic, and total symptoms are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39. |
| Change from baseline in RSV viral load (VL) | Day 2 to Day6, Day 13, Day 27 | RSV VL in nasopharyngeal samples from participants will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) |
| Change from baseline in RiiQ total score and domain scores | Day 3, Day 6, Day 13, Day 27 | RSV symptoms are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39. |
| Trough plasma concentration of AK0529 | Day 5 | Plasma concentration of AK0529 is reported. This outcome measure is planned to be analyzed for specified arm only. In this outcome measure, only those time points for which individual participants had data are reported. |
| Incidence and severity of treatment-emergent AEs (TEAEs), SAEs, and other AEs | Up to Day 27 | An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any clinically significant physical examinations, vital signs, clinical laboratory tests (including biochemistry, hematology, cardiac enzymes and urine analysis), 12-lead electrocardiograms (ECGs) and spirometry results were recorded as adverse events. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 27) was considered treatment-emergent. A Serious Adverse Events (SAEs) is any adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or results in a congenital anomaly. The severity of AEs/ SAEs is categorized by CTCAE6.0. |
Countries
China
Contacts
CONTACTChao Yu, Mater
Outcome results
None listed