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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
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
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
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
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Manchester University NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
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