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

Respiratory Syncytial Virus Infections Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03715023
• Other study ID #: PC_RSV_004
• Secondary ID: 2018-001667-24
• Status: Terminated
• Phase: Phase 2
• Start date: November 5, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: June 2019
• Source: Pulmocide Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 1, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Clatterbridge Cancer Centre NHS Foundation Trust	Liverpool
United Kingdom	St Georges University Hospital	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Nottingham University Hospital NHS Trust	Nottingham
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Pulmocide Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR)		Day 1 to Day 3
Primary	Proportion of participants reporting one or more treatment-emergent adverse event (TEAE)		Baseline to Day 28
Primary	Proportion of participants who discontinue due to an adverse event		Baseline to Day 28
Primary	Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose		Baseline to Day 28
Primary	Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose		Baseline to Day 28
Primary	Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose		Day 1 to Day 28
Primary	Proportion of participants who meet the markedly abnormal criteria for peak expiratory flow assessment at lease once post dose		Day 1 to Day 28
Secondary	Average change in RSV load measured in nasal secretion		Day 1 to Day 7
Secondary	Change in RSV load in nasal secretion		Baseline to Day 3
Secondary	Change in RSV load in nasal secretion		Baseline to Day 7
Secondary	Duration in viral shedding measured in nasal secretion		Day 1 to Day 28
Secondary	Determination of nasal concentrations of PC786		Days 1, 2, 3, 7, 14 and 28
Secondary	Maximum observed concentration (Cmax) of PC786 measured in plasma		Day 1, Pre-dose to 4 hours
Secondary	Trough plasma concentration (Ctrough) of PC786		Days 2 and 3, Pre-dose
Secondary	Area under the concentration versus time curve from time zero to time at 4 hours (AUC0-4) of PC786 in plasma		Day 1, Pre-dose to 4 hours
Secondary	Last quantifiable concentration (Ct last) of PC786 measured in plasma		Day 1, and multiple timepoints to Day 28
Secondary	Changes in RSV symptoms measured using a symptom diary card		Days 1, 2, 3, 4, 5, 6, 7, 14 and 28
Secondary	Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia		Day 1 to 28
Secondary	Proportion of participants progressing to invasive ventilation		Day 1 to 28
Secondary	Trends in oxygen saturation index		Day 1 to Day 7