A Study of AK0529 in Adults Patients Hospitalized With RS... | NCT06942299

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active drug: AK0529 fasting	Experimental	The participants will receive AK0529 twice daily for 5 days from D1 to D5.	Drug: AK0529
Active drug: AK0529 with meal	Experimental	The participants will receive AK0529 twice daily for 5 days from D1 to D5.	Drug: AK0529
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AK0529	Drug	Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting	Active drug: AK0529 fasting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of AE and SAE of subjects during the study period	An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect, or another important medical event.	Baseline up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale	Clinical improvement scale is mainly used to evaluate the overall severity level of the subject's disease with the highest score of 8 indicating death. A score of 6-7 represents severe hospitalization: a score of 6 requires mechanical ventilation, and a score of 7 requires not only mechanical ventilation but also angiogenic treatment, kidney dialysis, or artificial membrane lung. A score of 3-5 represents mild hospitalization: a score of 3 does not require oxygen therapy, a score of 4 requires a mask or nasal catheter, and a score of 5 requires noninvasive positive pressure ventilation or high-flow oxygen therapy. A score of 1-2 represents outpatient treatment: 1 is independent and 2 is in need of care (daily activities have an impact). A score of 0 means no treatment is required and there is no clinical or virological evidence of infection.

Eligibility Module

Eligibility Criteria

Main Inclusion criteria:

. Male or female patients of any ethnicity with an age of 18-85 years.
. Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.
. At least one of the following high-risk diseases or states for RSV infection
1. Asthma or chronic lung disease (such as COPD or cystic fibrosis),
2. immunocompromised,
3. Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
4. Chronic kidney disease,
5. Age ≥65 years old.
. With at least 1 new onset respiratory infection symptom or exacerbation of existing respiratory symptoms (respiratory symptoms include: sore throat, nasal congestion, runny nose, sneezing, coughing, wheezing, sputum production, shortness of breath), and any individual score is 2 or moderate.
. Onset of RSV infection symptoms should be ≤ 7 days.

Main Exclusion criteria:

. 3 days for drugs with potential antiviral effects on RSV such as ordinary interferon, 8 days for long-acting interferon, and 35 days for ribavirin for 5 half-lives before expected administration.
. Prohibited medicine are being used or planned to be used during the study treatment periods.
. Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
. Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
. Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
. Patients with autoimmune diseases who are in the induction treatment.
. HIV infection, CD4 count< 350 cells/mm3 with opportunistic infection and need treatment.
. Other patients who are judged by the investigator to be unsuitable for participating in the study, such as acute/chronic heart, lung, liver, kidney, rheumatic immunity, psychiatric, blood and other diseases in the unstable period.
. History of drug abuse within 12 months prior to screening.
. Allergy to the investigational drug or its component.
. Female patients with positive pregnancy test or breastfeeding.

Facility	Status	City	State	ZIP	Country	Contacts
The Second Perople's Hospital of Hefei		Hefei	Anhui		China
Huangshan City People's Hospital

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections