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

Sponsor

Pulmocide Ltd (Industry)

Overall Status

Terminated

CT.gov ID

NCT03715023

Collaborator

(none)

Enrollment

Locations

Arms

5.8

Actual Duration (Months)

0.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 5, 2018

Actual Primary Completion Date :

Feb 19, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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