Pulmonary AspergillosisPhase 2NCT05037851

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

A Phase 2 study testing Opelconazole in people with Pulmonary Aspergillosis, run by Pulmocide Ltd at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Aspergillosis
What is being tested?: Opelconazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 19 sitesin 2 countries
Study dates: 19 Nov 2021to 13 Nov 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

2. Participant has received either a single or double lung transplant but did not receive any other organ transplant (e.g., heart, kidney, etc.) at the time of the lung transplantation. History of prior transplant (>1 year) is acceptable
6a. (De novo prophylaxis immediately post transplant): participant must be ready to be randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive care unit (ICU) after the transplant surgery or
6b. (Pre-emptive therapy): participant must meet all of the following:
Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13 weeks) after a lung transplant. Colonization is defined according to the 2010 International Society for Heart Lung Transplantation (ISHLT) Consensus Statement definition criteria for colonization
Without evidence of pulmonary fungal disease
Must be ready to start anti-mold medication within 96 hours after the positive culture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported

Who cannot join

Participant would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy
Fungal disease requiring systemic antifungal treatment at the time of transplant
Has received a mold active antifungal agent post-transplant (Note: a participant who receives a mold active antifungal agent within 24 hours before, during, or after the transplant procedure will not be excluded if the mold active medication was stopped within 72 hours of returning to the ICU after the transplant surgery, or prior to randomization (whichever happens first)
Has previously received opelconazole
Is receiving, or who is due to receive at any time during the study, an investigational medicinal agent
Is participating, or who is due to participate at any time during the study, in a therapeutic clinical trial. For any other trials (e.g. observational or using approved medication), consultation with Pulmocide and the medical monitor is required.

Show all 12Show fewer

Has an endobronchial stent in situ
Known history of allergy, hypersensitivity, or any previous serious reaction to any component of the opelconazole formulation, azoles, echinocandins, or amphotericin B
Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) > 5 x the upper limit of normal (ULN)
Any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the participant from participation in the study
12. Life expectancy is not expected to be sustained for the duration of the trial (16 weeks), in the opinion of the investigator
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States17 sites

Clinical Research Site
Dallas, Texas, 75246
Clinical Research Site 1
Houston, Texas, 77030
Clinical Research Site 2
Houston, Texas, 77030
Clinical Research Site 3
Houston, Texas, 77030
Clinical Research Site
Jacksonville, Florida, 32224
Clinical Research Site
La Jolla, California, 92037
Clinical Research Site
Los Angeles, California, 90095
Clinical Research Site
Maywood, Illinois, 60153
Clinical Research Site
Nashville, Tennessee, 37232
Clinical Research Site
New York, New York, 10016
Clinical Research Site
Philadelphia, Pennsylvania, 19104
Clinical Research Site
Philadelphia, Pennsylvania, 19140
Clinical Research Site
Phoenix, Arizona, 85013
Clinical Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
St Louis, Missouri, 63110
Clinical Research Site
Tampa, Florida, 33606
Clinical Research Site
The Bronx, New York, 10467

Other trials in United States

Canada2 sites

Clinical Research Site
Edmonton, T6G 1Z1
Clinical Research Site
Toronto, M5G 2N2

Other trials in Canada

About this study

Official title: A Randomized Controlled Open-label Study to Assess the Safety and Tolerability of Nebulized PC945 for Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

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.

Read the detailed description

Part 1 of the study comprises a 12 week Prophylaxis or Pre-emptive Therapy Phase. Part 2 comprises a 4-week Safety Follow-Up Phase.

The study will screen single or double lung transplant recipients due to receive a mold-active antifungal: either as de novo prophylaxis or as pre-emptive therapy (for participants with Aspergillus spp. colonization of the respiratory tract but no evidence of pulmonary fungal disease). Only participants who fulfill all the inclusion and none of the exclusion criteria will be randomized.

Conditions: Pulmonary Aspergillosis
Being tested: Opelconazole, Standard of Care
Medical subject headings: Pulmonary Aspergillosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OpelconazoleDrug
Also called PC945
Nebulizer suspension
Standard of CareDrug
Standard of Care

Study groups in NCT05037851
Study group	Role	What they receive
Opelconazole	Experimental	Opelconazole administered for 12 weeks Receives: Drug: Opelconazole
Standard of Care (SoC)	Active comparator	Mold-active SoC Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants Who Completed 12 Weeks of Therapy
Percentage of Participants Who Completed 12 Weeks of PC945 or Initial Standard of Care (SoC)
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 202113 Nov 2023

First posted8 Sep 2021
Study start19 Nov 2021
Primary completion19 Oct 2023
Study completion13 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary AspergillosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open-label, randomized, active-controlled, parallel-group multi-center study
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05037851
Sponsor's protocol ID: PC_ASP_007
Status last verified: Oct 2024
First submitted: 31 Aug 2021
Last updated: 30 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Not yet recruitingPhase 1
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Chronic Pulmonary Aspergillosis
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
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All Pulmonary Aspergillosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Open-label Study to Assess the Safety and Tolerability of Nebulized PC945 for Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)
ClinicalTrials.gov ID: NCT05037851
Acronym / sponsor ID: PC_ASP_007
Conditions: Pulmonary Aspergillosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Pulmocide LtdIndustry (pharma, biotech, devices)
Study start: 19 Nov 2021 (actual)
Primary completion: 19 Oct 2023 (actual)
Study completion: 13 Nov 2023 (actual)
First posted: 8 Sep 2021 (actual)
Results: Posted 30 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Part 1 of the study comprises a 12 week Prophylaxis or Pre-emptive Therapy Phase. Part 2 comprises a 4-week Safety Follow-Up Phase.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Open-label, randomized, active-controlled, parallel-group multi-center study

Arm	Type	Receives
Opelconazole	Experimental	Drug: OpelconazoleOpelconazole administered for 12 weeks
Standard of Care (SoC)	Active comparator	Drug: Standard of CareMold-active SoC

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

2. Participant has received either a single or double lung transplant but did not receive any other organ transplant (e.g., heart, kidney, etc.) at the time of the lung transplantation. History of prior transplant (>1 year) is acceptable
6a. (De novo prophylaxis immediately post transplant): participant must be ready to be randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive care unit (ICU) after the transplant surgery or
Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13 weeks) after a lung transplant. Colonization is defined according to the 2010 International Society for Heart Lung Transplantation (ISHLT) Consensus Statement definition criteria for colonization
Without evidence of pulmonary fungal disease
Must be ready to start anti-mold medication within 96 hours after the positive culture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported

Key exclusion criteria (12 listed)

Participant would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy
Fungal disease requiring systemic antifungal treatment at the time of transplant
Has received a mold active antifungal agent post-transplant (Note: a participant who receives a mold active antifungal agent within 24 hours before, during, or after the transplant procedure will not be excluded if the mold active medication was stopped within 72 hours of returning to the ICU after the transplant surgery, or prior to randomization (whichever happens first)
Has previously received opelconazole
Is receiving, or who is due to receive at any time during the study, an investigational medicinal agent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OpelconazoleAlso: PC945Nebulizer suspension	Drug	Opelconazole
Standard of CareStandard of Care	Drug	Standard of Care (SoC)

Primary outcome

Proportion of Participants Who Completed 12 Weeks of Therapy
Time frame: Week 12
Percentage of Participants Who Completed 12 Weeks of PC945 or Initial Standard of Care (SoC)

Results and safety

Results posted to the registry on 30 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PC945	69	59
Standard of Care (SoC)	33	28

Primary outcome: Proportion of Participants Who Completed 12 Weeks of Therapy

Time frame: Week 12. Count of participants. Unit: Participants

Measure	PC945 n = 65	Standard of Care n = 33
Value	47	23

Population analysed: The Safety Population consisted of all randomized participants who received at least one dose of study therapy

Adverse events

Time frame: First dose of study therapy up to Week 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PC945	27 of 65 (41.5%)	59 of 65 (90.8%)	1 of 69
Standard of Care	12 of 33 (36.4%)	27 of 33 (81.8%)	2 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pulmonary Aspergillosis

Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Not yet recruitingPhase 1
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Chronic Pulmonary Aspergillosis
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vice President Clinical Development study director

Pulmocide Ltd

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opelconazole in people with Pulmonary Aspergillosis, run by Pulmocide Ltd at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who Completed 12 Weeks of Therapy (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.