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

Pulmocide

Status and phase: Terminated; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: PC786; Drug: SOC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03715023

PC_RSV_004

2018-001667-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Active + SoC

Experimental group

Description:

Daily doses of PC786 for 3 days + SoC

Treatment:

Drug: SOC

Drug: PC786

Placebo + SoC

Placebo Comparator group

Description:

Daily doses of Placebo for 3 days + SoC

Treatment:

Drug: SOC

Drug: Placebo