Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 19, 2019

Interventions

  • Drug: PC786
    • PC786 suspension for inhalation
  • Drug: Placebo
    • Placebo solution for inhalation
  • Drug: SOC
    • Standard treatment for RSV infection at study site

Arms, Groups and Cohorts

  • Experimental: Active + SoC
    • Daily doses of PC786 for 3 days + SoC
  • Placebo Comparator: Placebo + SoC
    • Daily doses of Placebo for 3 days + SoC

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pulmocide Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alison Murray, Study Director, Pulmocide Ltd

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