Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients

NCT03715023 | Terminated Phase 2

• 2 other identifiers: PC_RSV_0042018-001667-24
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 7

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV infection; Hematopoeitic stem cell transplant

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (13)

• 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

  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

Study Arms (2)

Active + SoC

EXPERIMENTAL

Daily doses of PC786 for 3 days + SoC

Drug: PC786; Drug: SOC

Placebo + SoC

PLACEBO COMPARATOR

Daily doses of Placebo for 3 days + SoC

Drug: Placebo; Drug: SOC

Interventions

PC786 DRUG

PC786 suspension for inhalation

Active + SoC

Placebo DRUG

Placebo solution for inhalation

Placebo + SoC

SOC DRUG

Standard treatment for RSV infection at study site

Active + SoC; Placebo + SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmocide Ltd: lead

Study Sites (7)

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

St Georges University Hospital

London, SW17 0QT, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Nottingham University Hospital NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

PC-786

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Alison Murray

  Pulmocide Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: November 5, 2018
• Primary Completion: February 19, 2019
• Study Completion: May 1, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

GB (7)