Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Metapneumovirus

In brief

The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Key facts

Study ID

NCT03502694

Run by

Janssen Research & Development, LLC

People needed

0

Starts

2018-11-05

Expected to finish

2020-10-28

Last updated by the study team

2018-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MemorialCare Research Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Lake Internal Medicine Associates — Eustis, Florida, United States
• Northwestern University - Northwestern Memorial Hospital - Infectious Disease Center — Chicago, Illinois, United States
• St Michaels Medical Center — Newark, New Jersey, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Hospital Regional Español — Bahía Blanca, Argentina
• Hospital Interzonal General de Agudos Dr. Jose Penna — Bahía Blanca, Argentina
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• CEMIC Saavedra — Ciudad de Buenos Aires, Argentina
• Hospital Italiano de La Plata — Ciudad de La Plata, Argentina
• Hospital Rawson — Córdoba, Argentina
• Hospital Privado-Universitario de Cordoba — Córdoba, Argentina
• Instituto Medico Platense — La Plata, Argentina
• Queen Elizabeth Hospital — Adelaide, Australia
• Flinders Medical Centre — Adelaide, Australia
• Princess Alexandra Hospital — Brisbane, Australia
• Barwon Health - University Hospital Geelong — Geelong, Australia
• Royal Melbourne Hospital — Melbourne, Australia
• Mater Hospital Brisbane — South Brisbane, Australia
• Westmead Hospital — Sydney, Australia
• Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul — Porto Alegre, Brazil
• Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo — Ribeirão Preto, Brazil
• Hospital Sirio Libanes — São Paulo, Brazil
• UCSF Fresno — Fresno, California, United States

Full record on ClinicalTrials.gov

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