Trial Summary
What is the purpose of this trial?
The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.
Research Team
CB
Colin Broom, MD
Principal Investigator
Pulmotect, Inc.
Eligibility Criteria
This trial is for patients with blood cancers or who have had a bone marrow transplant and are now suffering from lung infections caused by specific viruses (PIV, hMPV, or RSV). Participants should be diagnosed with these viral infections to qualify.Inclusion Criteria
Subjects with a nasopharyngeal swab positive for PIV, RSV, or hMPV by molecular assay
I understand the study and can give my consent.
I am following the required contraception guidelines.
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Exclusion Criteria
Patients with pulse oximetry of hemoglobin saturation less than 93% on room air
I have a history of chronic lung or heart conditions.
I had a stem cell transplant using my own cells more than 3 months ago.
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Treatment Details
Interventions
- PUL-042 (Virus Therapy)
Trial OverviewThe study is testing PUL-042, an experimental drug, against a placebo. It's given as an inhalation solution three times over six days to see if it can lessen the severity of lung infections in the patient group described.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PUL-042Experimental Treatment1 Intervention
PUL-042 Inhalation Solution
Group II: Sterile Saline for InhalationPlacebo Group1 Intervention
Placebo
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Who Is Running the Clinical Trial?
Pulmotect, Inc.
Lead Sponsor
Trials
7
Recruited
500+
Cancer Prevention Research Institute of Texas
Collaborator
Trials
55
Recruited
98,900+