A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Ark Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ziresovir (AK0529)
DrugActive Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Placebo
DrugActive Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Treatment groups
290 Participants
are divided into 3 treatment groupsGroup A: Active drug(200mg)Experimental treatment 1 intervention
Group B: Active drug(300mg)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time from first dose to resolution of LRTD symptoms
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 frame
Up to Day 27Secondary outcomes
1
Resolution rates of LRTD symptoms after treatment
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 frame
Day 3, Day 6, Day 13, Day 272
Time from first dose to resolution of upper respiratory, systemic, and total symptoms
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.
Time frame
Up to Day 273
Resolution rate of upper respiratory, systemic, and total symptoms
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.
Time frame
Day 3, Day 6, Day 13, Day 274
Change from baseline in RSV viral load (VL)
RSV VL in nasopharyngeal samples from participants will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR)
Time frame
Day 2 to Day6, Day 13, Day 27Other outcomes
1
Proportion of participants hospitalized
Proportion of outpatient participants who experienced at least one hospitalization during the study period.
Time frame
Up to Day 272
Hospitalization duration
Duration of hospitalization among participants who were hospitalized during the study period.
Time frame
Up to Day 273
Supplemental oxygen use
The proportion of participants who received supplemental oxygen at any point during the study, as well as the duration of use.
Time frame
Up to Day 274
ICU admission rate
The proportion of participants with at least one ICU admission during the study.
Time frame
Up to Day 27Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov