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.
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.
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
Canada2 sites
Clinical Research Site
Edmonton, T6G 1Z1
Clinical Research Site
Toronto, M5G 2N2
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Pulmocide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vice President Clinical Development, Study director, Pulmocide Ltd
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
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.
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.
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
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
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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?
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; AzTrials last refreshed its copy on 6 Nov 2026.