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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active + SoC

Daily doses of PC786 for 3 days + SoC

Group Type EXPERIMENTAL

PC786

Intervention Type DRUG

PC786 suspension for inhalation

SOC

Intervention Type DRUG

Standard treatment for RSV infection at study site

Placebo + SoC

Daily doses of Placebo for 3 days + SoC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for inhalation

SOC

Intervention Type DRUG

Standard treatment for RSV infection at study site

Interventions

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PC786

PC786 suspension for inhalation

Intervention Type DRUG

Placebo

Placebo solution for inhalation

Intervention Type DRUG

SOC

Standard treatment for RSV infection at study site

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No