Anti-RSV Study in Chinese Patients (ASCENT)
ASCENT
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
1 other identifier
interventional
160
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2019
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
March 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedNovember 27, 2019
November 1, 2019
10 months
October 5, 2018
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change of symptom score
To evaluate the change of patient-reported symptom score in AK0529 arms compared with the change in placebo arm after treatment. The scale is Wang bronchiolitis score and the total score is reported with a range from 0 to 12. A decreasing value of total score represents clinical improvement. Subscales are not applicable in this symptom score.
From Day 0 to Day 5
Incidence of adverse events during the study
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
From Day -3 to Day 14
Subject withdrawals due to treatment-emergent adverse events
A treatment-emergent adverse event (TEAE) is an AE that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state.
From Day -3 to Day 14
Secondary Outcomes (1)
Area under curve change of viral load
From Day 0 to Day 5
Study Arms (4)
100mg AK0529 Arm
EXPERIMENTALPatients randomised into this arm will be orally administered with 100mg AK0529 q.d. for five days.
200mg AK0529 Arm
EXPERIMENTALPatients randomised into this arm will be orally administered with 200mg AK0529 q.d. for five days.
300mg AK0529 Arm
EXPERIMENTALPatients randomised into this arm will be orally administered with 300mg AK0529 q.d. for five days.
Placebo Arm
PLACEBO COMPARATORPatients randomised into this arm will be orally administered with placebo q.d. for five days.
Interventions
AK0529 is a novel compound being developed for the treatment of RSV infection. The capsule containing enteric coated AK0529 pellets will be orally administered to patients at one of a 100mg, 200mg or 300mg dose level.
The placebo is made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed of microcrystaline cellulose pellet.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
Quanzhou First Hospital
Quanzhou, Fujian, 362000, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 571199, China
Sanya Central Hospital
Sanya, Hainan, 572000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
People's Hospital of Deyang City
Deyang, Sichuan, 618000, China
Suining Central Hopital
Suining, Sichuan, 629000, China
China-Japan Friendship Hospital
Beijing, 100029, China
Beijing Pinggu Hospital
Beijing, 101200, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
Nantong First People's Hospital
Nantong, 226001, China
Shanghai East Hospital
Shanghai, 200120, China
Central Hospital of Minhang District, Shanghai
Shanghai, 201199, China
Shenzhen People's Hospital
Shenzhen, 518001, China
Xiangtan Central Hospital
Xiangtan, 411100, China
Xinxiang First People's Hospital
Xinxiang, 453000, China
Affiliated Hospital of Zunyi Medical University
Zunyi, 563000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ark Clinical Trial
info@arkbiosciences.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
October 9, 2018
Study Start
March 29, 2019
Primary Completion
January 31, 2020
Study Completion
June 30, 2020
Last Updated
November 27, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share