Antiviral Activity, Clinical Outcomes, Safety, Tolerabili... | NCT03502694

NCT03502694

ID	Type	Description	Link
2017-001696-22	EudraCT Number
64041575MPN2001	Other Identifier	Janssen Research & Development, LLC

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen A (Low-Dose Lumicitabine)	Experimental	Participants will receive a single 750 milligram (mg) loading dose (LD) (Dose 1) of lumicitabine and matching placebo followed by nine 250 mg tablets as maintenance doses (MDs) (Doses 2 to 10) of lumicitabine and matching placebo administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).	Drug: Lumicitabine Drug: Placebo
Regimen B (High-Dose Lumicitabine)	Experimental	Participants will receive a single 1000 mg LD (Dose 1) of lumicitabine followed by nine 500 mg tablets as MDs (Doses 2 to 10) of lumicitabine and matching placebo tablet, administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).	Drug: Lumicitabine Drug: Placebo
Regimen C (Placebo)	Placebo Comparator	Participants will receive a placebo LD (Dose 1) followed by nine MDs (Doses 2 to 10) of matching placebo, administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumicitabine	Drug	Participants will receive loading dose and maintenance dose of lumicitabine tablets orally.	Regimen A (Low-Dose Lumicitabine) Regimen B (High-Dose Lumicitabine)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-Time Curve (AUC) of Human Metapneumovirus (hMPV) Viral Load	The AUC of hMPV ribonucleic acid (RNA) logarithm base 10 (log10) viral load (measured by quantitative real time reverse transcriptase polymerase chain reaction [qRT-PCR] in the mid-turbinate nasal swab specimens) is estimated by analyzing mean log10 viral load values over time using a restricted maximum likelihood based repeated measures approach.	Baseline up to Day 7

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants hospitalized (or in Emergency room prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization
Participants diagnosed with human metapneumovirus (hMPV) infection using a rapid polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria)
Participants with an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to (<=)5 days from the anticipated time of randomization
With the exception of the symptoms related to hMPV infection, participants must be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population, and/or the hMPV infection. This determination must be recorded in the participant's source documents and initialed by the investigator
A woman must have a negative urine pregnancy test (beta-human chorionic gonadotropin [b-hCG]) at screening

Exclusion Criteria:

Participants who are not expected to survive for more than 48 hours
Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization
Participants who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (for example, malignancy or genetic disorder) or medical therapy (for example, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant)
Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m^2)
Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Fresno		Fresno	California	93701	United States
MemorialCare Research Miller Children's and Women's Hospital Long Beach