Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Registration Number
- NCT03715023
- Lead Sponsor
- Pulmocide Ltd
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active + SoC PC786 Daily doses of PC786 for 3 days + SoC Active + SoC SOC Daily doses of PC786 for 3 days + SoC Placebo + SoC Placebo Daily doses of Placebo for 3 days + SoC Placebo + SoC SOC Daily doses of Placebo for 3 days + SoC
- Primary Outcome Measures
Name Time Method RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR) Day 1 to Day 3 Proportion of participants reporting one or more treatment-emergent adverse event (TEAE) Baseline to Day 28 Proportion of participants who discontinue due to an adverse event Baseline to Day 28 Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose Baseline to Day 28 Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose Baseline to Day 28 Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose Day 1 to Day 28 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 Outcome Measures
Name Time Method Average change in RSV load measured in nasal secretion Day 1 to Day 7 Change in RSV load in nasal secretion Baseline to Day 7 Duration in viral shedding measured in nasal secretion Day 1 to Day 28 Determination of nasal concentrations of PC786 Days 1, 2, 3, 7, 14 and 28 Maximum observed concentration (Cmax) of PC786 measured in plasma Day 1, Pre-dose to 4 hours Trough plasma concentration (Ctrough) of PC786 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 Day 1, Pre-dose to 4 hours Last quantifiable concentration (Ct last) of PC786 measured in plasma Day 1, and multiple timepoints to Day 28 Changes in RSV symptoms measured using a symptom diary card Days 1, 2, 3, 4, 5, 6, 7, 14 and 28 Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia Day 1 to 28 Proportion of participants progressing to invasive ventilation Day 1 to 28 Trends in oxygen saturation index Day 1 to Day 7
Trial Locations
- Locations (7)
Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, 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, United Kingdom