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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001667-24 | EudraCT Number |
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Practical issues that could not be resolved resulting in recruitment difficulties at sites.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active + SoC | Experimental | Daily doses of PC786 for 3 days + SoC |
|
| Placebo + SoC | Placebo Comparator | Daily doses of Placebo for 3 days + SoC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC786 | Drug | PC786 suspension for inhalation |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in RSV load measured in nasal secretion | Day 1 to Day 7 | |
| Change in RSV load in nasal secretion | Baseline to Day 3 | |
| Change in RSV load in nasal secretion |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Murray | Pulmocide Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom | |||
| Bristol Haematology and Oncology Centre |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000626983 | PC-786 |
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| Drug |
Placebo solution for inhalation |
|
| SOC | Drug | Standard treatment for RSV infection at study site |
|
| 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 |
| Bristol |
| BS2 8ED |
| United Kingdom |
| Clatterbridge Cancer Centre NHS Foundation Trust | Liverpool | L7 8XP | United Kingdom |
| St Georges University Hospital | London | SW17 0QT | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| Nottingham University Hospital NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| D014777 | Virus Diseases |
| D007239 | Infections |