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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715023
Recruitment Status : Terminated (Practical issues that could not be resolved resulting in recruitment difficulties at sites.)
First Posted : October 22, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: PC786 Drug: Placebo Drug: SOC Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Placebo
Placebo solution for inhalation

Drug: SOC
Standard treatment for RSV infection at study site




Primary Outcome Measures :
  1. RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR) [ Time Frame: Day 1 to Day 3 ]
  2. Proportion of participants reporting one or more treatment-emergent adverse event (TEAE) [ Time Frame: Baseline to Day 28 ]
  3. Proportion of participants who discontinue due to an adverse event [ Time Frame: Baseline to Day 28 ]
  4. 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 ]
  5. Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose [ Time Frame: Baseline to Day 28 ]
  6. 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 ]
  7. 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 ]

Secondary Outcome Measures :
  1. Average change in RSV load measured in nasal secretion [ Time Frame: Day 1 to Day 7 ]
  2. Change in RSV load in nasal secretion [ Time Frame: Baseline to Day 3 ]
  3. Change in RSV load in nasal secretion [ Time Frame: Baseline to Day 7 ]
  4. Duration in viral shedding measured in nasal secretion [ Time Frame: Day 1 to Day 28 ]
  5. Determination of nasal concentrations of PC786 [ Time Frame: Days 1, 2, 3, 7, 14 and 28 ]
  6. Maximum observed concentration (Cmax) of PC786 measured in plasma [ Time Frame: Day 1, Pre-dose to 4 hours ]
  7. Trough plasma concentration (Ctrough) of PC786 [ Time Frame: Days 2 and 3, Pre-dose ]
  8. 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 ]
  9. Last quantifiable concentration (Ct last) of PC786 measured in plasma [ Time Frame: Day 1, and multiple timepoints to Day 28 ]
  10. Changes in RSV symptoms measured using a symptom diary card [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 14 and 28 ]
  11. Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia [ Time Frame: Day 1 to 28 ]
  12. Proportion of participants progressing to invasive ventilation [ Time Frame: Day 1 to 28 ]
  13. Trends in oxygen saturation index [ Time Frame: Day 1 to Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715023


Locations
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United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, L7 8XP
St Georges University Hospital
London, United Kingdom, SW17 0QT
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom, NG5 1PB
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Pulmocide Ltd
Investigators
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Study Director: Alison Murray Pulmocide Ltd

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Responsible Party: Pulmocide Ltd
ClinicalTrials.gov Identifier: NCT03715023    
Other Study ID Numbers: PC_RSV_004
2018-001667-24 ( EudraCT Number )
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pulmocide Ltd:
RSV infection
Hematopoeitic stem cell transplant
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Antiviral Agents
PC786
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action