Clinical trial NCT03699202: Anti-RSV Study in Chinese Patients (ASCENT)
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Orally Administered AK0529 in Adults With Respiratory Syncytial Virus Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV,AK0529,Chinese
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered AK0529 in Chinese adults with RSV infection.

Detailed description: This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study in Chinese adult outpatients with RSV infection. Approximately 160 eligible patients who have been recently diagnosed with RSV infection are planned to be enrolled into the study. Symptom scores of patients before and after treatment will be evaluated. Meanwhile, nasopharyngeal samples and blood samples will be collected for virological and pharmacokinetics evaluations. The evaluation of the safety and tolerability will include AE/SAE, vital signs, physical examination, laboratory examination and 12-lead ECGs. The total study duration for each patient will be 20 days.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 75 years, inclusive.
* Confirmed with RSV infection by rapid diagnostic testing.
* New onset with documentation of the following symptoms within 72 hours prior to the start of screening: Respiratory symptoms: runny nose, stuffy nose, sneezing, sore throat, earache, cough, shortness of breath; Systemic symptoms: headache, fatigue / lethargy, fever, and muscle and / or joint ache. The patient must have four symptoms of above, and at least one of these must be respiratory symptom in nature.
* Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

* The patient has taken, is taking or needs to take any antiviral medication (e.g. ribavirin, Chinese medicine or herbs with effects of treating respiratory tract infection) within the 72 hours prior to screening.
* Awareness of concomitant infections of respiratory viruses (eg, influenza A, B), bacterial or fungal infections, including systemic bacterial or fungal infections within 7 days prior to screening or during the screening period.
* Patient frailty was evaluated as "Vulnerable" or worse according to the Clinical Frailty Scale with a score ≥ 4 at screening.
* Awareness of having positive results on HBsAg or HCV antibody or HIV (HIV 1 or HIV 2).
* Patient with active tuberculosis or is taking antituberculosis treatment.
* Patient with severe gastrointestinal disease which could impact drug absorption, eg, vomiting, malabsorption syndrome, or short bowel syndrome caused by necrotizing enterocolitis.
* Patient with any congenital heart disease, acute or chronic heart failure, ischemic heart disease, or congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation.
* Patient with malignant tumor.
* Patient has received or is waiting for bone marrow, stem cell or solid organ transplantation.
* Patient with any immune-related disease to be treated within 12 months prior to screening.
* Patient with clinical laboratoy test values of ≥ 2x the upper limit of normal (ULN) for alanine aminotransferase or aspartate aminotransferase, or \>1x ULN for total bilirubin, or \>1.5xULN for serum creatinine.
* Patient with electrolyte disorders, eg, hypokalemia, hypocalcemia, or hypomagnesemia.
* Patient with history of drug or alcohol abuse within 12 months prior to screening ("alcohol abuse" definition is \>14 units per week: 1 unit = 10mL Alcohol, or 250mL of 4% beer, or 25 mL of 40% spirit, or 75 mL of 13% wine).
* Patient has allergy or hypersensitivity to study medication or its compositions.
* Female patient with positive pregnancy test result or is lactating.
* Patient with fertility refusing to use medically effective contraceptives during the study or within three months of the end of study.
* Patient participated in an investigational drug or device study within 60 days prior to screening.
* Patient who in the opinion of the investigator, is deemed as ineligible for the study, including patients who are with active psychiatric disease, or are taking psychiatric medication.

Primary outcomes:
measure: Change of symptom score
timeFrame: From Day 0 to Day 5
measure: Incidence of adverse events during the study
timeFrame: From Day -3 to Day 14
measure: Subject withdrawals due to treatment-emergent adverse events
timeFrame: From Day -3 to Day 14
Secondary outcomes:
measure: Area under curve change of viral load
timeFrame: From Day 0 to Day 5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Sanya
country: China
facility: Sanya Central Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
state: Jiangsu
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Deyang
country: China
facility: People's Hospital of Deyang City
state: Sichuan
city: Suining
country: China
facility: Suining Central Hopital
state: Sichuan
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Nantong
country: China
facility: Nantong First People's Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Central Hospital of Minhang District, Shanghai
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
city: Xinxiang
country: China
facility: Xinxiang First People's Hospital
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
Study officials:
affiliation: info@arkbiosciences.com
name: Ark Clinical Trial
role: STUDY_DIRECTOR
References: