PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
NCT ID: NCT06665100
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-06-27
2026-05-31
Brief Summary
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Detailed Description
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The first 50 patients will either be low dose PUL-042 or placebo. After review of the safety data from the initial patients, the PUL-042 dose may be increased. Subjects will be evaluated by chest x-ray and clinical status for respiratory complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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PUL-042
PUL-042 Inhalation Solution
PUL-042
Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution
Sterile Saline for Inhalation
Placebo
Placebo
Sterile Saline for Inhalation
Interventions
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PUL-042
Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution
Placebo
Sterile Saline for Inhalation
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have undergone active cytotoxic chemotherapy within 6 months or subjects who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib, mycophenolate mofetil, corticosteroids ≥1mg/kg prednisone equivalent).
3. Subjects who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an Immunodeficiency Scoring Index (ISI) , of greater or equal to 4.
4. Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.
5. Subjects must be symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough and must be dosed within 6 days from the onset of symptoms.
6. Chest X-ray with a Radiologic Severity Index (RSI) score of 6 or lower.
7. Subjects must have pulse oximetry of hemoglobin saturation ≥ 93% on room air.
8. Spirometry (forced expiratory volume in one second \[FEV1\] and forced vital capacity \[FVC\]) ≥70% of predicted value.
9. Adult (≥ 18 years of age).
10. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.
11. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.
12. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.
13. Ability to understand and give informed consent.
Exclusion Criteria
2. Known history of chronic pulmonary disease (e.g., asthma \[including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection\], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.
3. Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30 days.
4. Exposure to any investigational agent (defined as any non-FDA-approved agent) within 30 days, or 5 half-lives of the investigational agent, whichever is longer, prior to the Screening Visit.
5. Allogeneic HSCT recipients with an ISI of 3 or less.
6. Autologous HSCT recipients more than 3 months after the transplant procedure.
7. Patients with a relapsed and/or refractory underlying hematologic malignancy with a life expectancy of less than 2 months.
8. HSCT recipients in the pre-engraftment period.
9. Chest X-ray with an RSI of \>6.
10. Patients documented to be positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days prior to the Screening Visit, as determined by local testing (additional screening testing is not required).
11. Clinically significant bacteremia or fungemia within 7 days prior to the Screening Visit that has not been adequately treated, as determined by the Principal Investigator.
12. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.
13. Previous exposure to PUL-042 Inhalation Solution.
18 Years
ALL
No
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
Pulmotect, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Colin Broom, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmotect, Inc.
Locations
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City of Hope National Medical Center
Duarte, California, United States
Northside Hospital
Atlanta, Georgia, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Lineberger Cancer
Chapel Hill, North Carolina, United States
OU Health Physicians - Infectious Disease Clinic
Oklahoma City, Oklahoma, United States
University of Texas MD Anderson MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP120014
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PUL-042-207
Identifier Type: -
Identifier Source: org_study_id
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