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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02135614




Registration number
NCT02135614
Ethics application status
Date submitted
8/05/2014
Date registered
12/05/2014
Date last updated
24/09/2018

Titles & IDs
Public title
Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
Secondary ID [1] 0 0
2014-002137-58
Secondary ID [2] 0 0
GS-US-218-1227
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Presatovir
Treatment: Drugs - Presatovir placebo

Experimental: Presatovir - Participants will receive a single dose of presatovir.

Placebo Comparator: Presatovir placebo - Participants will receive a single dose of presatovir placebo.


Treatment: Drugs: Presatovir
Presatovir 200 mg (4 x 50 mg tablets) administered orally

Treatment: Drugs: Presatovir placebo
Presatovir placebo tablets administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5 - The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Timepoint [1] 0 0
Baseline to Day 5
Secondary outcome [1] 0 0
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5 - The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Timepoint [1] 0 0
Baseline to Day 5
Secondary outcome [2] 0 0
Number of Hospitalization-Free Days Following Presatovir Administration
Timepoint [2] 0 0
Up to Day 28
Secondary outcome [3] 0 0
Rate of Unplanned Medical Encounters - The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.
Timepoint [3] 0 0
Up to Day 28

Eligibility
Key inclusion criteria
Key

- Current inpatient

- New onset of acute respiratory infectious symptoms, or acute worsening of chronic
symptoms related to ongoing respiratory disease for = 5 days prior to screening:

- Upper respiratory tract symptoms: nasal congestion, runny nose, sore throat, or
earache

- Lower respiratory tract symptoms: cough, sputum production, wheezing, dyspnea, or
chest tightness

- Documented to be RSV-positive at the current admission within 72 hours of screening,
or as evaluated at screening

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Related to concomitant or previous medication use:

- Use of oral prednisone or other corticosteroid equivalent to:

- > 20 mg/day for > 14 days prior to screening is not permitted.

- > 20 mg/day for = 14 days, including corticosteroids received during current
hospitalization (ie, bolus doses), is permitted.

- = 20 mg/day, regardless of duration, is permitted.

- Individuals taking a moderate or strong cytochrome P450 enzyme (CYP) inducer
including but not limited to rifampin, St John's Wort, carbamazepine, phenytoin,
efavirenz, bosentan, etracirine, modafinil, and nafcillin within 2 weeks prior to
the first dose of study drug

- Related to medical history:

- Pregnant, breastfeeding, or lactating females

- Individuals requiring > 50% supplemental oxygen (while the individual is awake)
at screening

- Individuals with a Clinical Frailty Scale (CFS) > 7 at Baseline

- Known significant abnormality altering the anatomy of the nose or nasopharynx
that in, the opinion of the investigator, will preclude obtaining adequate nasal
swab sampling in either nasal passage

- Waiting for or recently (within the past 12 months) received a bone marrow, stem
cell, or solid organ transplant, or who have received radiation or chemotherapy
within 12 months prior to Screening

- Individuals with HIV/AIDS and a known CD4 count < 200 cells/uL

- History of severe dementia or Alzheimer's disease

- History of drug and/or alcohol abuse that, in the opinion of the investigator,
may prevent adherence to study activities

- Related to medical condition at screening:

- Influenza-positive as determined by local diagnostic test

- Known Middle East Respiratory Syndrome coronavirus (MERS-CoV) infection or known
coinfection with other coronavirus

- Use of mechanical ventilation during the current admission, not including
noninvasive ventilation

- Clinically significant bacteremia or fungemia that has not been adequately
treated prior to Screening, as determined by the investigator

- Inadequate treatment of confirmed bacterial, fungal, or non-RSV pneumonia, as
determined by the investigator

- Excessive nausea/vomiting at admission, as determined by the investigator, that
precludes administration of an orally administered study drug

- Related to allergies:

- Known allergy to components of the study drug (microcrystalline cellulose,
mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium
dioxide, polyethylene glycol and talc)

- Documented history of acute (anaphylaxis) or delayed (Stevens-Johnson syndrome or
epidermal necrolysis) allergy to sulfa drugs

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [5] 0 0
Monash Medical Center - Clayton
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
- New Lambton
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Redcliffe
Recruitment postcode(s) [4] 0 0
- Southport
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Belgium
State/province [8] 0 0
Anderlecht
Country [9] 0 0
France
State/province [9] 0 0
Hauts-de-Seine
Country [10] 0 0
France
State/province [10] 0 0
Brest
Country [11] 0 0
France
State/province [11] 0 0
Clamart
Country [12] 0 0
France
State/province [12] 0 0
Colombes
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Israel
State/province [14] 0 0
Beer Sheva
Country [15] 0 0
Israel
State/province [15] 0 0
Holon
Country [16] 0 0
Israel
State/province [16] 0 0
Jerusalem
Country [17] 0 0
Israel
State/province [17] 0 0
Kefar-Sava
Country [18] 0 0
Israel
State/province [18] 0 0
Nahariya
Country [19] 0 0
Israel
State/province [19] 0 0
Nazareth
Country [20] 0 0
Israel
State/province [20] 0 0
Petah Tikva
Country [21] 0 0
Israel
State/province [21] 0 0
Ramat Gan
Country [22] 0 0
Israel
State/province [22] 0 0
Tel Aviv
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Bucheon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Incheon
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Netherlands
State/province [27] 0 0
Zutphen
Country [28] 0 0
New Zealand
State/province [28] 0 0
Bay Of Plenty
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Hamilton
Country [31] 0 0
Poland
State/province [31] 0 0
Wroclaw
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Southampton
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Telford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the effects of presatovir on respiratory
syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute
respiratory infectious symptoms.

Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose.
Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change
in viral load as the primary endpoint.
Trial website
https://clinicaltrials.gov/show/NCT02135614
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications