UMIN-CTR Clinical Trial

Public title

A Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Older Adults

Acronym

A Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Older Adults

Scientific Title

A Prospective Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Adults Aged 65 Years and Older in Japan

Scientific Title:Acronym

A Prospective Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Adults Aged 65 Years and Older in Japan

Region

Japan

Condition

Respiratory Syncytial Virus Infections

Classification by specialty

Pneumology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to estimate the attack rate of respiratory syncytial virus (RSV)-acute respiratory disease (ARD) in adults aged 65 years and older in Japan.

Basic objectives2

Others

Basic objectives -Others

The number of Protocol Defined Respiratory Syncytial Virus (RSV)-Acute Respiratory Disease (ARD) Confirmed by Reverse
Transcriptase Polymerase Chain Reaction (RT-PCR)

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Number of Participants with Protocol Defined Respiratory Syncytial Virus (RSV)-Acute Respiratory Disease (ARD) Confirmed by Reverse
Transcriptase Polymerase Chain Reaction (RT-PCR) during study period (up to Week 52)

Key secondary outcomes

-Number of Participants with Protocol Defined Respiratory Syncytial Virus(RSV)-Lower Respiratory Tract Disease (LRTD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) during study period (up to Week 52)
-Incidence of Mortality Associated with RSV-ARD
-Duration of RSV-ARD
-Signs and Symptoms Associated with RSV-ARD
-Number of Participants with Hospitalization, Outpatient Visit, and Emergency Room (ER) Visit due to RSV-ARD
-Number of Participants with ARD caused by Different Types of Respiratory Pathogens Other Than RSV
-Duration of ARD due to Different Types of Respiratory Pathogens Other Than RSV
-Signs and Symptoms Associated with ARD Caused by Different Types of Respiratory Pathogens Other Than RSV
-Number of Participants with Hospitalization, Outpatient Visit, and Emergency Room (ER) Visit due to ARD Caused by the Different
Types of Respiratory Pathogens Other Than RSV
-Percentage of Participants with RSV-LRTD
by Age-Group, Underlying Comorbidities, Immunosuppression Status, Functional Status and Place of Residence

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

999

years-old

>

Gender

Male and Female

Key inclusion criteria

Participants are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for selfcare and activities of daily living such as:
a.) able to take care of all shopping needs independently;
b.) able to travel independently;
c.)able to operate telephone on their own (make or receive calls);
d.) responsible for taking medication in correct dosages at correct time;
e.) able to perform daily self-care such as bathing, changing clothes, using
toilet and grooming
- Participants may have one or more chronic medical diagnoses but should be clinically stable as assessed by absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator,render survival to completion of the protocol unlikely
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment
- Able to comply with study requirements; including access to transportation for study visits

Key exclusion criteria

-Participants received any experimental antiviral drugs or vaccines against respiratory syncytial virus (RSV) within 6 months prior to the signing Informed Consent Form (ICFs)
- Participants who have acute respiratory disease (ARD) at the time of ICF and Week 0 (Baseline) at the discretion of the investigator
- Participants with life expectancy less than 1 year
- Participants unwilling to undergo nasopharyngeal swab procedures or with any physical abnormality which limits the ability to collect regular nasopharyngeal specimens
- Participant who is not able to comply with study-related procedures,due to their mental status or severe clinical condition, based on clinical judgement of the investigator

Target sample size

1000

Name of lead principal investigator

1st name	Hirotaka
Middle name
Last name	Numaguchi

Organization

Janssen Pharmaceutical K.K.

Division name

R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.

Zip code

101-0065

Address

3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan

TEL

03-4411-7700

Email

HNumaguc@its.jnj.com

Name of contact person

1st name	Maho
Middle name
Last name	Yamada

Organization

Janssen Pharmaceutical K.K.

Division name

R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.

Zip code

101-0065

Address

3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan

TEL

03-4411-7700

Homepage URL

http://pam.sylogent.com/cr/CR108658

Email

myamada1@its.jnj.com

Institute

Janssen Pharmaceutical K.K.
R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.

Institute

Department

Personal name

Organization

Janssen Pharmaceutical K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kitamachi Clinic Ethic Committee

Address

1-1-3, Kichijoji-Kitamachi, Musashino, Tokyo

Tel

03-6779-8166

Email

shingo-namiki@j-smo.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

公益財団法人宮城厚生協会　坂総合病院(宮城県），医療法人社団仁智会　鈴木内科クリニック（東京都），医療法人社団 ささきクリニック（兵庫県），よしむらクリニック（熊本県），医療法人　小田辺内科医院（福岡県），医療法人社団　埼忠禎会　埼葛クリニック（埼玉県），山一ビル内科クリニック（東京都），のぐち内科クリニック（東京都），医療法人社団　山田医院（千葉県），医療法人相生会 ピーエスクリニック（福岡県）
／Saka GeneralHospital(Miyagi),SuzukiClinic Internal Medicine(Tokyo),Sasaki Clinic(Hyogo),Yoshimura Clinic(Kumamoto), Otabe Clinic(Fukuoka), Saikatsu Clinic(Saitama), Yamaichi Building Medical Clinic(Tokyo), Noguchi Naika Clinic(Tokyo), Yamada Clinic(Chiba),SOUSEIKAI PS Clinic(Fukuoka)

Date of disclosure of the study information

2019

Year

09

Month

02

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042819

Publication of results

Published

URL related to results and publications

http://doi.org/10.1111/irv.12928

Number of participants that the trial has enrolled

1000

Results

Respiratory syncytial virus was reported as a major pathogen for respiratory infection and represents a significant burden in the Japanese elderly population.

Results date posted

2021

Year

05

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021

Year

11

Month

03

Day

Baseline Characteristics

There was a higher proportion of females (551/1,000 [55.1%] subjects) than males (449/1,000 [44.9%] subjects). The median age of all subjects was 74.0 years (range: 65 to 93 years); and more than half of subjects (543/1,000 [54.3%]) were in the age category of 65 to 74 years. The majority of subjects were home residents (996/1,000 [99.6%]), living with family/cohabiter (809/1,000 [(80.9%] subjects), nonsmokers (576/1,000 [57.6%] subjects), and had been vaccinated with influenza vaccine in 2019/2020 (645/1,000 [64.5%] subjects). At baseline, most of the subjects (998/1,000 [99.8%] subjects) had a functional status of >16 evaluated by Barthel Index of Activities of Daily Living.
A total of 958/1,000 (95.8%) subjects had at least 1 coexisting medication condition. The most common (reported in >10% of subjects) medical condition was asthma (104/1,000 [10.4%] subjects) among conditions with increased risk for severe RSV. Metabolism and nutrition disorders (646/1,000 [64.6%] subjects) and vascular disorders (576/1,000 [57.6%] subjects) were the most commonly (>50% of subjects) reported coexisting medical conditions by system organ class.

Participant flow

A total of 1,000 subjects were enrolled in the study. Of these, 913 (91.3%) subjects completed the study and 87 (8.7%) discontinued the study. The reasons for discontinuation were consent withdrawal (58 [5.8%] subjects), lost to follow-up (22 [2.2%] subjects), death (6 [0.6%] subjects), and repeated failure to comply with protocol requirements (1 [0.1%] subject). Of the 87 discontinued subjects, 32 (3.2%), 16 (1.6%), and 39 (3.9%) subjects had discontinued before the start of RSV season, during the RSV season, and after the RSV season until the end of the study, respectively.
Overall, 313 (31.3%) subjects had 459 ARD visits.
A total of 6 subjects discontinued the study due to death, however, none of the subjects died due to AEs associated with nasopharyngeal swab sample collection, RSV-ARD, or ARD caused by different types of respiratory pathogens other than RSV during the whole study period.

Adverse events

Only 1/1,000 (0.1%) subjects had an AE during this study. This subject experienced an AE of epistaxis related to nasopharyngeal swab sampling collection. The outcome of the event was reported as resolved on the same day of onset.
None of the subjects had death as an outcome and no subject reported with an SAE during the study.

Outcome measures

Primary endpoint:
A total of 24/1,000 (2.4%; 95% CI: 1.54, 3.55) subjects had 1 episode of RSV-ARD; 13/1,000 (1.3%; 95% CI: 0.69, 2.21) and 11/1,000 (1.1%, 95% CI: 0.55, 1.96) subjects had RSV-ARD of Subtype A and Subtype B, respectively.
？
Secondary endpoints:
Occurrence of RSV-LRTD: A total of 8/1,000 (0.8%; 95% CI: 0.35, 1.57) subjects had 1 episode of RSV-LRTD which was defined as new onset or worsening of at least 1 symptom of LRTI, assessed by the investigator.
Outcome of RSV-ARD: The median (range) duration of RSV-ARD was 18.0 (10 to 33) days. A total of 24/1,000 (2.4%) subjects during the whole study period had utilized the medical services of outpatient visits and 1/24 (4.2%) subjects was hospitalized for 10 days for RSV-ARD.
Occurrence of ARD Caused by Different Types of Respiratory Pathogens Other Than RSV: The most common viruses other than RSV that caused ARD (detected in >10 subjects) were human rhinovirus/enterovirus (100/1,000 [10.0%; 95% CI: 8.21, 12.03] subjects), parainfluenza 3 (20/1,000 [2.0%; 95% CI: 1.23, 3.07] subjects), coronavirus OC43 and human metapneumovirus (12/1,000 [1.2%; 95% CI: 0.62, 2.09] subjects each), and influenza A/H1 (11/1,000 [1.1%; 95% CI: 0.55, 1.96] subjects). Only 1 subject reported ARD due to influenza B virus.
Outcome of ARD Caused by Different Types of Respiratory Pathogens Other Than RSV: The median (range) duration of ARD (detected in >10 subjects) caused by viruses other than RSV was 20.5 (10 to 36) days for human metapneumovirus, 15.5 (9 to 31) days for parainfluenza 3, 15.0 (5 to 55) days for human rhinovirus/enterovirus, 15.0 (5 to 38) days for influenza A/H1, and 12.5 (6 to 35) days for coronavirus OC43. A total of 93/100 (93.0%) subjects who had ARD due to human rhinovirus/enterovirus; 12/12 (100.0%) subjects each due to coronavirus OC43 and human metapneumovirus; 17/20 (85.0%) subjects due to parainfluenza 3; 9/11 (81.8%) subjects due to influenza A/H1 had utilized the medical service of outpatient visit. One subject each who had ARD due to human metapneumovirus and influenza A/H1 was hospitalized.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

01

Month

11

Day

Date of IRB

2019

Year

03

Month

20

Day

Anticipated trial start date

2019

Year

04

Month

11

Day

Last follow-up date

2020

Year

07

Month

06

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is prospective observational cohort study.
Recruitment had been conducted at clinical study institutions and had been completed.

Registered date

2019

Year

09

Month

02

Day

Last modified on

2021

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042819