Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients (TreatRSV1)

June 10, 2019 updated by: Pulmocide Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Liverpool, United Kingdom, L7 8XP
        • Clatterbridge Cancer Centre NHS Foundation Trust
      • London, United Kingdom, SW17 0QT
        • St Georges University Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospital NHS Trust
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active + SoC
Daily doses of PC786 for 3 days + SoC
Drug: PC786
PC786 suspension for inhalation
Drug: SOC
Standard treatment for RSV infection at study site
Placebo Comparator: Placebo + SoC
Daily doses of Placebo for 3 days + SoC
Drug: SOC
Standard treatment for RSV infection at study site
Drug: Placebo
Placebo solution for inhalation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Proportion of participants reporting one or more treatment-emergent adverse event (TEAE)
Time Frame: Baseline to Day 28
Baseline to Day 28
Proportion of participants who discontinue due to an adverse event
Time Frame: Baseline to Day 28
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
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
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
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
Day 1 to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Average change in RSV load measured in nasal secretion
Time Frame: Day 1 to Day 7
Day 1 to Day 7
Change in RSV load in nasal secretion
Time Frame: Baseline to Day 3
Baseline to Day 3
Change in RSV load in nasal secretion
Time Frame: Baseline to Day 7
Baseline to Day 7
Duration in viral shedding measured in nasal secretion
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Determination of nasal concentrations of PC786
Time Frame: Days 1, 2, 3, 7, 14 and 28
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
Day 1, Pre-dose to 4 hours
Trough plasma concentration (Ctrough) of PC786
Time Frame: Days 2 and 3, Pre-dose
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
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
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
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
Day 1 to 28
Proportion of participants progressing to invasive ventilation
Time Frame: Day 1 to 28
Day 1 to 28
Trends in oxygen saturation index
Time Frame: Day 1 to Day 7
Day 1 to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulmocide Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alison Murray, Pulmocide Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PC_RSV_004
  • 2018-001667-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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