Respiratory Syncytial VirusPhase 2NCT02254408
Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
A Phase 2 study testing Presatovir in people with Respiratory Syncytial Virus, run by Gilead Sciences at 68 sites in 15 countries.
Trial summary
The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus
- 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
- 68 sitesin 15 countries
- Study dates
- 23 Jan 2015to 14 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received an autologous or allogeneic HCT using any conditioning regimen
- Documented to be RSV-positive as determined by local testing (eg, polymerase chain reaction, direct fluorescence antibody, respiratory viral panel assay, or culture) using an upper respiratory tract sample collected ≤ 6 days prior to Day 1
- New onset of at least 1 of the following respiratory symptoms for ≤ 7 days prior to Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of these chronic (associated with a previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ≤ 7 days prior to Day 1
- No evidence of new abnormalities consistent with lower respiratory tract infection (LRTI) on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is not available or was not obtained during standard care < 48 hours prior to screening, a chest X-ray must be obtained for screening
- O2 saturation ≥ 92% on room air
- An informed consent document signed and dated by the participant or a legal guardian of the participant and the investigator or his/her designee
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- A negative urine or serum pregnancy test is required for female participants (unless surgically sterile or greater than two years post-menopausal)
- Male and female participants of childbearing potential must agree to contraceptive requirements as described in the study protocol
- Willingness to complete necessary study procedures and have available a working telephone or email
Who cannot join
- Related to concomitant or previous medication use:
- Use of non-marketed (according to region) investigational agents within 30 days, OR use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT
- Related to medical history:
- Pregnant, breastfeeding, or lactating females
- Unable to tolerate nasal sampling required for this study, as determined by the investigator
- Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month
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- 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:
- Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus) within 7 days prior to the screening visit, as determined by local testing (additional testing is not required)
- Clinically significant bacteremia or fungemia within 7 days prior to screening that has not been adequately treated, as determined by the investigator
- Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to screening that has not been adequately treated, as determined by the investigator
- Excessive nausea/vomiting at screening, as determined by the investigator, or an inability to swallow pills that precludes oral administration of the investigational medical product (for participants without an nasogastric tube in place)
- Any condition which, in the opinion of the investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints
- Related to laboratory results:
- Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)
- Clinically significant aspartate aminotransferase/alanine aminotransferase, as determined by the investigator
- Clinically significant total bilirubin, as determined by the investigator
Trial locations and contacts
68 sites in 15 countries.
68 sites in 15 countries
United States27 sites
University of Michigan
Ann Arbor, Michigan
Emory University
Atlanta, Georgia
NorthSide Medical Center
Atlanta, Georgia
John Hopkins
Baltimore, Maryland
Dana Farber Cancer Institute
Boston, Massachusetts
University of Massachusetts Memorial Cancer Center
Boston, Massachusetts
Northwestern University
Chicago, Illinois
University of Chicago
Chicago, Illinois
University Hospital Case Medical
Cleveland, Ohio
Wayne State University
Detroit, Michigan
City of Hope
Duarte, California
Duke University
Durham, North Carolina
MD Anderson Cancer Center
Houston, Texas
UCLA David Geffen School of Medicine
Los Angeles, California
Loyola University
Maywood, Illinois
Medical College of Wisconsin
Milwaukee, Wisconsin
University of Minnesota
Minneapolis, Minnesota
Vanderbilt University Medical Center
Nashville, Tennessee
Memorial Sloan Kettering
New York, New York
New York Presbyterian Hospital Cornell Medical Center
New York, New York
Mayo Clinic Arizona
Phoenix, Arizona
Oregon Health Sciences University
Portland, Oregon
University of Utah
Salt Lake City, Utah
Texas Transplant Institute (SCRI)
San Antonio, Texas
Fred Hutchison Cancer Research Center
Seattle, Washington
Washington University
St Louis, Missouri
Stanford University
Stanford, California
Brazil7 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre
Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto
São Paulo
Fundação Antonio Prudente - Hospital do Câncer AC Camargo
São Paulo
Hospital Israelita Albert Einstein
São Paulo
Hospital Santa Marcelina
São Paulo
Hospital Universitario USP
São Paulo
Instituto Brasileiro de Controle do Câncer-IBCC
São Paulo
Israel6 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
South Korea5 sites
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul Saint Mary's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
France4 sites
CHU de Bordeaux
Bordeaux
Hopital Saint-Louis, APHP
Paris
Hopital Foch
Suresnes
Institut Universitaire du Cancer Oncopole
Toulouse
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Chang Gung Medical Foundation-LinKou Branch
Taoyuan
Australia3 sites
Royal Brisbane & Women's Hospital
Herston
Royal Melbourne Hospital
Melbourne
Westmead Hospital
Westmead, New South Wales
Canada2 sites
Tom Baker Cancer Centre
Calgary
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Netherlands2 sites
VUmc cancer center
Amsterdam
Erasmus Medical Center (Rotterdam)
Rotterdam
Singapore2 sites
Singapore General Hospital
Singapore
UMC National University Health System
Singapore
United Kingdom2 sites
Leeds Teaching Hospitals Trust
Leeds
King's College Hospital
London
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 Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract
The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Presatovir, Placebo
- Keywords
- Respiratory Syncytial Virus (RSV), Antiviral, Hematopoietic Cell Transplant (HCT), Upper respiratory tract infection
- Medical subject headings
- Respiratory Tract 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 × 50 mg tablets) administered orally or via nasogastric (NG) tube
PlaceboDrug
Tablets administered orally or via nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| Presatovir | Experimental | Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56. Receives: Drug: Presatovir |
| Placebo | Placebo comparator | Participants will receive placebo on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9
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; Day 9
Percentage of Participants Who Developed a Lower Respiratory Tract Complication
A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee:
- Primary RSV lower respiratory tract infection (LRTI)
- Secondary bacterial LRTI
- LRTI due to unusual pathogens
- Lower respiratory tract complication of unknown etiology
Measured: Up to Day 28
Secondary outcomes (1)
Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality
Participants were considered to have an event if either condition is met:
- Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or;
- Participant dies prior to or on Day 28
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 posted1 Oct 2014 (estimated)
- Study start23 Jan 2015
- Primary completion14 Jul 2017
- Study completion14 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT02254408
- Sponsor's protocol ID
- GS-US-218-0108
- Other IDs
- 2014-002474-36, 2014
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2014
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chemaly RF, Dadwal SS, Bergeron A, Ljungman P, Kim YJ, Cheng GS, Pipavath SN, Limaye AP, Blanchard E, Winston DJ, Stiff PJ, Zuckerman T, Lachance S, Rahav G, Small CB, Mullane KM, Patron RL, Lee DG, Hirsch HH, Waghmare A, McKevitt M, Jordan R, Guo Y, German P, Porter DP, Gossage DL, Watkins TR, Marty FM, Chien JW, Boeckh M. A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients. Clin Infect Dis. 2020 Dec 31;71(11):2777-2786. doi: 10.1093/cid/ciz1166.
PubMed 31793991
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 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 Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract
- ClinicalTrials.gov ID
- NCT02254408
- Acronym / sponsor ID
- GS-US-218-0108
- Conditions
- Respiratory Syncytial Virus
- Keywords
- Respiratory Syncytial Virus (RSV), Antiviral, Hematopoietic Cell Transplant (HCT), Upper respiratory tract infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2015 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 6 Aug 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 effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presatovir | Experimental | Drug: PresatovirParticipants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Received an autologous or allogeneic HCT using any conditioning regimen
- Documented to be RSV-positive as determined by local testing (eg, polymerase chain reaction, direct fluorescence antibody, respiratory viral panel assay, or culture) using an upper respiratory tract sample collected ≤ 6 days prior to Day 1
- New onset of at least 1 of the following respiratory symptoms for ≤ 7 days prior to Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of these chronic (associated with a previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ≤ 7 days prior to Day 1
- No evidence of new abnormalities consistent with lower respiratory tract infection (LRTI) on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is not available or was not obtained during standard care < 48 hours prior to screening, a chest X-ray must be obtained for screening
- O2 saturation ≥ 92% on room air
Key exclusion criteria (17 listed)
- Use of non-marketed (according to region) investigational agents within 30 days, OR use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT
- Pregnant, breastfeeding, or lactating females
- Unable to tolerate nasal sampling required for this study, as determined by the investigator
- Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month
- History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities
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 × 50 mg tablets) administered orally or via nasogastric (NG) tube | Drug | Presatovir |
| PlaceboTablets administered orally or via nasogastric tube | Drug | Placebo |
Primary outcome
Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9
Time frame: Baseline; Day 9
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.
Percentage of Participants Who Developed a Lower Respiratory Tract Complication
Time frame: Up to Day 28
A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: * Primary RSV lower respiratory tract infection (LRTI) * Secondary bacterial LRTI * LRTI due to unusual pathogens * Lower respiratory tract complication of unknown etiology
1 secondary outcome
Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality
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 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31793991Chemaly RF, Dadwal SS, Bergeron A, Ljungman P, Kim YJ, Cheng GS, Pipavath SN, Limaye AP, Blanchard E, Winston DJ, Stiff PJ, Zuckerman T, Lachance S, Rahav G, Small CB, Mullane KM, Patron RL, Lee DG, Hirsch HH, Waghmare A, McKevitt M, Jordan R, Guo Y, German P, Porter DP, Gossage DL, Watkins TR, Marty FM, Chien JW, Boeckh M. A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients. Clin Infect Dis. 2020 Dec 31;71(11):2777-2786. doi: 10.1093/cid/ciz1166.
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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
68 sites in 15 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, run by Gilead Sciences at 68 sites in 15 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 9 inclusion and 17 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Brazil, Israel, South Korea, France and 10 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 6 Aug 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 Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9 (time frame: Baseline; Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02254408, which also lists 1 linked publication.
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 6 Aug 2018.