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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug(200mg) | Experimental | The participants will receive 200 mg AK0529 twice daily for 5 days from D1 to D5. |
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| Active drug(300mg) | Experimental | The participants will receive 300 mg AK0529 twice daily for 5 days from D1 to D5. |
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| Placebo | Placebo Comparator | The participants will receive placebo of 200 mg, or 300 mg twice daily for 5 days from D1 to D5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziresovir (AK0529) | Drug | Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants hospitalized | Proportion of outpatient participants who experienced at least one hospitalization during the study period. | Up to Day 27 |
| Hospitalization duration | Duration of hospitalization among participants who were hospitalized during the study period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Yu, Mater | Contact | +86 021-50681677 | chao.yu@arkbiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | China |
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This clinical study is a randomized placebo-controlled parallel multi-center phase 2b/3 trial.
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Double-Blind
| Placebo | Drug | Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral |
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| Day 3, Day 6, Day 13, Day 27 |
| 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. | Up to Day 27 |
| 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. | Day 3, Day 6, Day 13, Day 27 |
| 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) | Day 2 to Day6, Day 13, Day 27 |
| Change from baseline in RiiQ total score and domain scores | 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. | Day 3, Day 6, Day 13, Day 27 |
| Trough plasma concentration of AK0529 | 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. | Day 5 |
| Incidence and severity of treatment-emergent AEs (TEAEs), SAEs, and other AEs | 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. | Up to Day 27 |
| Up to Day 27 |
| Supplemental oxygen use | The proportion of participants who received supplemental oxygen at any point during the study, as well as the duration of use. | Up to Day 27 |
| ICU admission rate | The proportion of participants with at least one ICU admission during the study. | Up to Day 27 |
| Guangzhou Medical University Panyu Central Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Cangzhou Hospital of Integrated TCM-WM | Recruiting | Cangzhou | Hebei | China |
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| The First Affiliated Hospital of Nanyang Medical College | Recruiting | Nanyang | Henan | China |
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| Henan Infectious Disease Hospital (The Sixth People's Hospital of Zhengzhou) | Not yet recruiting | Zhengzhou | Henan | China |
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| Wuhan Sixth Hospital | Recruiting | Wuhan | Hubei | China |
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| Zhejiang Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| People's Hospital of Rui'an City | Recruiting | Rui’an | Zhejiang | China |
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| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000707852 | ziresovir |
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