Respiratory Syncytial Virus MedDRA version: 20.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: PC786
Pharmaceutical Form: Powder for nebuliser suspension
INN or Proposed INN: Not applicable
Current Sponsor code: PC786
Sponsors
Pulmocide Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any potential study subject must satisfy all of the following criteria to be eligible to enter the study. The subject is/has: 1.Received an allogeneic or autologous HSCT using any conditioning regimen 2.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 these symptoms, if these symptoms are chronic (i.e., associated with a prior diagnosis, such as chronic rhinorrhoea, seasonal allergy or chronic lung disease) 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 or computerised tomography thorax 3.A positive RSV diagnostic test result on a sample collected from the nose or pharynx =2 days before Day 1 (may be =3 days before Day 1 only if the sample is collected on a Friday) 4.Provided written informed consent 5.Aged =18 years of age at the time of consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Any potential study subject who meets any of the following criteria below will be excluded from participating in this study. The subject: 1.Is intubated and requires invasive ventilation OR is likely to require invasive ventilation in the next 3 days 2.Has received any investigational RSV vaccine after HSCT 3.Has received any monoclonal anti-RSV antibodies within 4 months or 5 half-lives before screening, whichever is longer 4.Requires treatment (or is known to require treatment) with intravenous ribavirin prior to subject being randomised in the study 5.Is documented to be positive for parainfluenza within 7 days before the screening visit 6.Is documented to be positive for influenza on a sample collected from the nose or pharynx =2 days before Day 1 7.Has clinically significant bacteraemia or fungaemia within 7 days before screening that has not been adequately treated 8.Has clinically significant bacterial, fungal, or viral pneumonia (due to a virus other than RSV) within 2 weeks before screening that has not been adequately treated 9.Is precluded from participating in this study as a result of treatment with another investigational drug or participation in another clinical trial 10.If female, is pregnant, lactating or breast feeding 11.Has any other disease or condition which in the Investigator's medical opinion would preclude the subject's participation in a clinical trial 12.Is receiving an antiretroviral protease inhibitor 13.Has chronic, active hepatitis infection 14.Has any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the subject from participation in the study 15.Is employed by or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site or any contract research organisation involved in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the anti-viral effect of inhaled PC786 compared with placebo when added to standard of care (SoC) RSV treatment in haematopoietic stem cell transplant (HSCT) recipients with acute RSV infection •To assess the safety and tolerability of 3 days of inhaled PC786 in HSCT subjects with acute RSV infection ; Secondary Objective: •To compare the anti-viral effect of PC786 with that of placebo on RSV load measured in nasal secretions •To obtain estimates of PC786 concentrations in nasal MLF and plasma •To evaluate the effect of PC786 on clinical features of RSV disease •To evaluate the effect of PC786 in preventing development of lower respiratory tract infection (LRTI) in subjects with infection confined to the upper respiratory tract (URT) at enrolment •To obtain estimates for important clinical endpoints ; Primary end point(s): •Slope of the RSV load over Days 1–3 measured in nasal secretions by reverse transcription quantitative polymerase chain reaction (RT-qPCR) •Safety will be assessed using: oAdverse events (AEs) oTwelve-lead electrocardiogram (ECGs) oVital signs oClinical laboratory evaluations (haematology, clinical chemistry, urinalysis) oPeak expiratory flow (PEF) oPhysical examination ; Timepoint(s) of evaluation of this end point: Nasal secretions (RT-qPCR) - Days 1, 2, 3,4,5,6,7,14 and 28 AEs - continuous collecting (Screening to day 28) 12-lead ECGs - Baseline, Day 1, 2, 3,7 and 28 Vital signs - Baseline, Days 1, 2, 3,7 and 28 Clinical laboratory evaluations - Days 1, 2, 3, 7 and 28 PEF | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Additional anti-viral endpoints (to be determined by RT-qPCR on nasal secretions) will include: -Time-weighted average change in RSV load from Day 1 to Day 7 (DAVG7) -Change in RSV load from baseline (before first dose of PC786 or placebo) to Day 3 -Change in RSV load from baseline (before first dose of PC786 or placebo) to Day 7 -Duration of viral shedding •PC786 concentration (measured in nasal MLF) •PC786 pharmacokinetic parameters measured in plasma (e.g., area under the concentration versus time curve [AUC], trough plasma concentration [Ctrough] and maximum observed concentration [Cmax]) •Effect of PC786 on RSV symptoms (assessed using a subject-reported symptom diary card) •Development of LRTI or pneumonia (due to RSV or secondary [bacterial or fungal] infection) •Progression to invasive ventilation •Trends on oxygen saturation index over Days 1–7 ; Timepoint(s) of evaluation of this end point: Nasal secretions (RT-qPCR) - Days 1, 2, 3,4,5,6,7,14 and 28 Nasal MLF PK analysis - Days 1, 2,3,7,14 and 28 Blood for PK - Days 1,2,3, 7, 14 and 28 LRTI assessment - Days 1, 2,3,7,14 and 28 (additional days if hospitalised - days 4,5, and 6) PEF - Days 1,2,3, 7, 14 and 28 Symptom scores - Days 1,2,3,4,5,6,7, 14 and 28 | — |
Countries
United Kingdom
Contacts
Public ContactDirector of Clinical Development
Pulmocide Ltd
Outcome results
None listed