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Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients (TreatRSV1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715023
Recruitment Status : Terminated (Practical issues that could not be resolved resulting in recruitment difficulties at sites.)
First Posted : October 22, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pulmocide Ltd

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE November 5, 2018
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR) [ Time Frame: Day 1 to Day 3 ]
  • Proportion of participants reporting one or more treatment-emergent adverse event (TEAE) [ Time Frame: Baseline to Day 28 ]
  • Proportion of participants who discontinue due to an adverse event [ Time Frame: Baseline to Day 28 ]
  • Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose [ Time Frame: Baseline to Day 28 ]
  • Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose [ Time Frame: Baseline to Day 28 ]
  • Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose [ Time Frame: Day 1 to Day 28 ]
  • Proportion of participants who meet the markedly abnormal criteria for peak expiratory flow assessment at lease once post dose [ Time Frame: Day 1 to Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Average change in RSV load measured in nasal secretion [ Time Frame: Day 1 to Day 7 ]
  • Change in RSV load in nasal secretion [ Time Frame: Baseline to Day 3 ]
  • Change in RSV load in nasal secretion [ Time Frame: Baseline to Day 7 ]
  • Duration in viral shedding measured in nasal secretion [ Time Frame: Day 1 to Day 28 ]
  • Determination of nasal concentrations of PC786 [ Time Frame: Days 1, 2, 3, 7, 14 and 28 ]
  • Maximum observed concentration (Cmax) of PC786 measured in plasma [ Time Frame: Day 1, Pre-dose to 4 hours ]
  • Trough plasma concentration (Ctrough) of PC786 [ Time Frame: Days 2 and 3, Pre-dose ]
  • Area under the concentration versus time curve from time zero to time at 4 hours (AUC0-4) of PC786 in plasma [ Time Frame: Day 1, Pre-dose to 4 hours ]
  • Last quantifiable concentration (Ct last) of PC786 measured in plasma [ Time Frame: Day 1, and multiple timepoints to Day 28 ]
  • Changes in RSV symptoms measured using a symptom diary card [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 14 and 28 ]
  • Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia [ Time Frame: Day 1 to 28 ]
  • Proportion of participants progressing to invasive ventilation [ Time Frame: Day 1 to 28 ]
  • Trends in oxygen saturation index [ Time Frame: Day 1 to Day 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients
Official Title  ICMJE A Double Blind, Placebo-controlled Study to Assess the Anti-viral Effect, Safety and Tolerability of Inhaled PC786 for the Treatment of Acute Respiratory Syncytial Virus (RSV) Infection in Adult Hematopoietic Stem Cell Transplant Recipients
Brief Summary This study tests the effects of an experimental drug PC786 in people infected with Respiratory Syncytial Virus (RSV). PC786 may be useful in treating patients infected with RSV as it works by interfering with the way the virus multiplies. PC786 is an inhaled medicine. Participants will be treated with SoC treatment (e.g. oral ribavirin and/or IV immunoglobulin), half of the participants will receive PC786 in addition and half will receive a placebo treatment. The study will take place at multiple sites in UK and will include approximately 30 participants. The maximum study duration will be about 4 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Syncytial Virus Infections
Intervention  ICMJE
  • Drug: PC786
    PC786 suspension for inhalation
  • Drug: Placebo
    Placebo solution for inhalation
  • Drug: SOC
    Standard treatment for RSV infection at study site
Study Arms  ICMJE
  • Experimental: Active + SoC
    Daily doses of PC786 for 3 days + SoC
    Interventions:
    • Drug: PC786
    • Drug: SOC
  • Placebo Comparator: Placebo + SoC
    Daily doses of Placebo for 3 days + SoC
    Interventions:
    • Drug: Placebo
    • Drug: SOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
5
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
30
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Received an allogeneic or autologous hematopoietic stem cell transplant (HSCT) using any conditioning regimen
  • Experienced new onset of at least one of the following respiratory symptoms ≤5 days before study Day 1:

Nasal congestion or stuffiness, runny nose (rhinorrhoea), cough, or sore throat OR Worsening of at least one of those symptoms, if symptoms are chronic OR Wheezing, sputum production, pleuritic chest pain, increased respiratory rate, signs on chest auscultation, hypoxia, increased supplemental oxygen requirement or new infiltrates on chest X-ray/CT

  • A positive RSV diagnostic test
  • Provided written informed consent

Exclusion Criteria:

  • Is intubated and requires invasive ventilation
  • Has received any investigational RSV vaccine after HSCT, or has received any monoclonal anti-RSV antibodies within 4 months or 5 half-lives before participation
  • Treatment with intravenous ribavirin
  • Positive for test for influenza or parainfluenza
  • Significant untreated bacteraemia or fungaemia
  • Significant untreated bacterial, fungal, or viral pneumonia
  • Precluded from participating as a result of treatment with another investigational drug or participation in another clinical trial
  • Other disease or condition which would preclude the subject's participation in a clinical trial
  • Is receiving an antiretroviral protease inhibitor
  • Has chronic, active hepatitis infection
  • Known alcohol or drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715023
Other Study ID Numbers  ICMJE PC_RSV_004
2018-001667-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pulmocide Ltd
Study Sponsor  ICMJE Pulmocide Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alison Murray Pulmocide Ltd
PRS Account Pulmocide Ltd
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP