Respiratory Syncytial Virus InfectionPhase 2NCT02135614
Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
A Phase 2 study testing Presatovir in people with Respiratory Syncytial Virus Infection, run by Gilead Sciences at 43 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- Presatovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 43 sitesin 11 countries
- Study dates
- 9 Jun 2014to 12 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
43 sites in 11 countries.
43 sites in 11 countries
United States9 sites
Anne Arundel Medical Center
Annapolis, Maryland
Northwestern Memorial Hospital
Chicago, Illinois
Henry Ford Health System
Detroit, Michigan
Marshfield Clinic Research Foundation
Marshfield, Wisconsin
Vanderbilt Medical Group and Clinic
Nashville, Tennessee
New York Presbyterian Hospital
New York, New York
Rochester General Hospital
Rochester, New York
William Beaumont
Royal Oak, Michigan
University of Washington
Seattle, Washington
Israel9 sites
Soroka Medical Center
Beersheba
Edith Wolfson Medical Center
Holon
Hadassah University Hospital Ein Kerem
Jerusalem
Meir Medical Center
Kefar Sava
Western Galilee Hospital-Nahariya
Nahariya
The Nazareth Hospital
Nazareth
Rabin Medical Center
Petah Tikva
Chaim Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv
Australia6 sites
Monash Medical Center
Clayton, Victoria
Frankston Hospital
Frankston, Victoria
John Hunter Hospital
New Lambton, New South Wales
Redcliffe Hospital
Redcliffe, Queensland
Gold Coast Hospital
Southport, Queensland
Westmead Hospital
Westmead, New South Wales
France6 sites
CHRU Brest - Hospital Cavale Blanche
Brest
Hopital d'Instructions des Armees Percy
Clamart
Hopital Louis Mourier
Colombes
Hopital Saint Louis - Service de Pneumologie
Paris
Hopital Tenon
Paris
Hopital Foch
Suresnes, Hauts-de-Seine
South Korea4 sites
Soon Chun Hyang University Hospital
Bucheon-si
Gachon University Gil Hospital
Incheon
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
New Zealand3 sites
Middlemore Hospital
Auckland
Waikato Hospital
Hamilton
Tauranga Hospital
Tauranga, Bay of Plenty
United Kingdom2 sites
Southampton University Hospitals NHS Trust
Southampton
Princess Royal Hospital
Telford
About this study
Official 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
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.
- Conditions
- Respiratory Syncytial Virus Infection
- Being tested
- Presatovir, Presatovir placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PresatovirDrug
Also called GS-5806
Presatovir 200 mg (4 x 50 mg tablets) administered orally
Presatovir placeboDrug
Presatovir placebo tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Presatovir | Experimental | Participants will receive a single dose of presatovir. Receives: Drug: Presatovir |
| Presatovir placebo | Placebo comparator | Participants will receive a single dose of presatovir placebo. Receives: Drug: Presatovir placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 5
Secondary outcomes (3)
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.
Measured: Baseline to Day 5
Number of Hospitalization-Free Days Following Presatovir Administration
Measured: Up to Day 28
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.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start9 Jun 2014
- Primary completion27 Mar 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135614
- Sponsor's protocol ID
- GS-US-218-1227
- Other IDs
- 2014-002137-58, 2014
- Status last verified
- May 2018
- First submitted
- 8 May 2014
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02135614
- Acronym / sponsor ID
- GS-US-218-1227
- Conditions
- Respiratory Syncytial Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2014 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presatovir | Experimental | Drug: PresatovirParticipants will receive a single dose of presatovir. |
| Presatovir placebo | Placebo comparator | Drug: Presatovir placeboParticipants will receive a single dose of presatovir placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Documented to be RSV-positive at the current admission within 72 hours of screening, or as evaluated at screening
Key exclusion criteria (26 listed)
- Related to concomitant or previous medication use:
- Related to medical history:
- Related to medical condition at screening:
- Related to allergies:
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PresatovirAlso: GS-5806Presatovir 200 mg (4 x 50 mg tablets) administered orally | Drug | Presatovir |
| Presatovir placeboPresatovir placebo tablets administered orally | Drug | Presatovir placebo |
Primary outcome
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5
Time frame: 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.
3 secondary outcomes
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5
Time frame: Baseline to Day 5
Number of Hospitalization-Free Days Following Presatovir Administration
Time frame: Up to Day 28
Rate of Unplanned Medical Encounters
Time frame: Up to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
43 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Presatovir in people with Respiratory Syncytial Virus Infection, run by Gilead Sciences at 43 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Israel, Australia, France, South Korea and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5 (time frame: Baseline to Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.