Respiratory Syncytial Virus InfectionsPhase 2TreatRSV1NCT03715023
Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients
A Phase 2 study testing PC786 and SOC in people with Respiratory Syncytial Virus Infections, run by Pulmocide Ltd at 7 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- PC786 and SOC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 5 Nov 2018to 1 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8XP
St Georges University Hospital
London, SW17 0QT
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Nottingham University Hospital NHS Trust
Nottingham, NG5 1PB
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
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
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- PC786, Placebo, SOC
- Keywords
- RSV infection, Hematopoeitic stem cell transplant
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC786Drug
PC786 suspension for inhalation
PlaceboDrug
Placebo solution for inhalation
SOCDrug
Standard treatment for RSV infection at study site
| Study group | Role | What they receive |
|---|---|---|
| Active + SoC | Experimental | Daily doses of PC786 for 3 days + SoC Receives: Drug: PC786; Drug: SOC |
| Placebo + SoC | Placebo comparator | Daily doses of Placebo for 3 days + SoC Receives: Drug: Placebo; Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR)
Measured: Day 1 to Day 3
Proportion of participants reporting one or more treatment-emergent adverse event (TEAE)
Measured: Baseline to Day 28
Proportion of participants who discontinue due to an adverse event
Measured: Baseline to Day 28
Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose
Measured: Baseline to Day 28
Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Measured: Baseline to Day 28
Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
Measured: Day 1 to Day 28
Proportion of participants who meet the markedly abnormal criteria for peak expiratory flow assessment at lease once post dose
Measured: Day 1 to Day 28
Secondary outcomes (13)
Average change in RSV load measured in nasal secretion
Measured: Day 1 to Day 7
Change in RSV load in nasal secretion
Measured: Baseline to Day 3
Change in RSV load in nasal secretion
Measured: Baseline to Day 7
Duration in viral shedding measured in nasal secretion
Measured: Day 1 to Day 28
Determination of nasal concentrations of PC786
Measured: Days 1, 2, 3, 7, 14 and 28
Maximum observed concentration (Cmax) of PC786 measured in plasma
Measured: Day 1, Pre-dose to 4 hours
Trough plasma concentration (Ctrough) of PC786
Measured: 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
Measured: Day 1, Pre-dose to 4 hours
Last quantifiable concentration (Ct last) of PC786 measured in plasma
Measured: Day 1, and multiple timepoints to Day 28
Changes in RSV symptoms measured using a symptom diary card
Measured: Days 1, 2, 3, 4, 5, 6, 7, 14 and 28
Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia
Measured: Day 1 to 28
Proportion of participants progressing to invasive ventilation
Measured: Day 1 to 28
Trends in oxygen saturation index
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start5 Nov 2018
- Primary completion19 Feb 2019
- Study completion1 May 2019
Why it stopped: Practical issues that could not be resolved resulting in recruitment difficulties at sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmocide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison Murray, Study director, Pulmocide Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715023
- Sponsor's protocol ID
- PC_RSV_004
- Other IDs
- 2018-001667-24, 2018
- Acronym
- TreatRSV1
- Status last verified
- Jun 2019
- First submitted
- 17 Oct 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03715023
- Acronym / sponsor ID
- TreatRSV1 / PC_RSV_004
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV infection, Hematopoeitic stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Practical issues that could not be resolved resulting in recruitment difficulties at sites.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Pulmocide LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active + SoC | Experimental | Drug: PC786, Drug: SOCDaily doses of PC786 for 3 days + SoC |
| Placebo + SoC | Placebo comparator | Drug: Placebo, Drug: SOCDaily doses of Placebo for 3 days + SoC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC786PC786 suspension for inhalation | Drug | Active + SoC |
| PlaceboPlacebo solution for inhalation | Drug | Placebo + SoC |
| SOCStandard treatment for RSV infection at study site | Drug | Active + SoC, Placebo + SoC |
Primary outcome
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
13 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Practical issues that could not be resolved resulting in recruitment difficulties at sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Murray study director
Pulmocide Ltd
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PC786 and SOC in people with Respiratory Syncytial Virus Infections, run by Pulmocide Ltd at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Practical issues that could not be resolved resulting in recruitment difficulties at sites.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR) (time frame: Day 1 to Day 3). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.