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

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
PC786
Placebo
SOC
Sponsored by
Pulmocide Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring RSV infection, Hematopoeitic stem cell transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Heartlands Hospital
  • Bristol Haematology and Oncology Centre
  • Clatterbridge Cancer Centre NHS Foundation Trust
  • St Georges University Hospital
  • Manchester University NHS Foundation Trust
  • Nottingham University Hospital NHS Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active + SoC

Placebo + SoC

Arm Description

Daily doses of PC786 for 3 days + SoC

Daily doses of Placebo for 3 days + SoC

Outcomes

Primary Outcome Measures

RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR)
Proportion of participants reporting one or more treatment-emergent adverse event (TEAE)
Proportion of participants who discontinue due to an adverse event
Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose
Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
Proportion of participants who meet the markedly abnormal criteria for peak expiratory flow assessment at lease once post dose

Secondary Outcome Measures

Average change in RSV load measured in nasal secretion
Change in RSV load in nasal secretion
Change in RSV load in nasal secretion
Duration in viral shedding measured in nasal secretion
Determination of nasal concentrations of PC786
Maximum observed concentration (Cmax) of PC786 measured in plasma
Trough plasma concentration (Ctrough) of PC786
Area under the concentration versus time curve from time zero to time at 4 hours (AUC0-4) of PC786 in plasma
Last quantifiable concentration (Ct last) of PC786 measured in plasma
Changes in RSV symptoms measured using a symptom diary card
Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia
Proportion of participants progressing to invasive ventilation
Trends in oxygen saturation index

Full Information

First Posted
October 17, 2018
Last Updated
June 10, 2019
Sponsor
Pulmocide Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03715023
Brief Title
Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients
Acronym
TreatRSV1
Official Title
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
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Practical issues that could not be resolved resulting in recruitment difficulties at sites.
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
February 19, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmocide Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
RSV infection, Hematopoeitic stem cell transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active + SoC
Arm Type
Experimental
Arm Description
Daily doses of PC786 for 3 days + SoC
Arm Title
Placebo + SoC
Arm Type
Placebo Comparator
Arm Description
Daily doses of Placebo for 3 days + SoC
Intervention Type
Drug
Intervention Name(s)
PC786
Intervention Description
PC786 suspension for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for inhalation
Intervention Type
Drug
Intervention Name(s)
SOC
Intervention Description
Standard treatment for RSV infection at study site
Primary Outcome Measure Information:
Title
RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR)
Time Frame
Day 1 to Day 3
Title
Proportion of participants reporting one or more treatment-emergent adverse event (TEAE)
Time Frame
Baseline to Day 28
Title
Proportion of participants who discontinue due to an adverse event
Time Frame
Baseline to Day 28
Title
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
Title
Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Time Frame
Baseline to Day 28
Title
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
Title
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 Outcome Measure Information:
Title
Average change in RSV load measured in nasal secretion
Time Frame
Day 1 to Day 7
Title
Change in RSV load in nasal secretion
Time Frame
Baseline to Day 3
Title
Change in RSV load in nasal secretion
Time Frame
Baseline to Day 7
Title
Duration in viral shedding measured in nasal secretion
Time Frame
Day 1 to Day 28
Title
Determination of nasal concentrations of PC786
Time Frame
Days 1, 2, 3, 7, 14 and 28
Title
Maximum observed concentration (Cmax) of PC786 measured in plasma
Time Frame
Day 1, Pre-dose to 4 hours
Title
Trough plasma concentration (Ctrough) of PC786
Time Frame
Days 2 and 3, Pre-dose
Title
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
Title
Last quantifiable concentration (Ct last) of PC786 measured in plasma
Time Frame
Day 1, and multiple timepoints to Day 28
Title
Changes in RSV symptoms measured using a symptom diary card
Time Frame
Days 1, 2, 3, 4, 5, 6, 7, 14 and 28
Title
Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia
Time Frame
Day 1 to 28
Title
Proportion of participants progressing to invasive ventilation
Time Frame
Day 1 to 28
Title
Trends in oxygen saturation index
Time Frame
Day 1 to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Murray
Organizational Affiliation
Pulmocide Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
St Georges University Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Nottingham University Hospital NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

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

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