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An Open-label Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

NCT05037851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-04-30

Study results available
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Summary

A study to evaluate the safety and tolerability of opelconazole for the prevention of fungal aspergillus infections in the lung in participants who have received a lung transplant.

Conditions

  • Pulmonary Aspergillosis

Interventions

DRUG

Opelconazole

Nebulizer suspension

DRUG

Standard of Care

Standard of Care

Sponsors & Collaborators

  • Pulmocide Ltd

    lead INDUSTRY

Principal Investigators

  • Vice President Clinical Development · Pulmocide Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2023-10-19
Completion
2023-11-13
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037851 on ClinicalTrials.gov