Actively Recruiting
PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
Led by Pulmotect, Inc. · Updated on 2026-04-24
100
Participants Needed
11
Research Sites
96 weeks
Total Duration
On this page
Sponsors
P
Pulmotect, Inc.
Lead Sponsor
C
Cancer Prevention Research Institute of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive test for parainfluenza virus, RSV, or human metapneumovirus by molecular assay
- Diagnosed with hematologic malignancies like leukemia, lymphoma, or multiple myeloma, or recipient of allogeneic or autologous hematopoietic stem cell transplant for these diseases
- Received active cytotoxic chemotherapy within 6 months or currently on immunosuppressive therapy
- Allogeneic stem cell transplant recipients must have a high Immunodeficiency Scoring Index (ISI) of 4 or more
- Autologous stem cell transplant recipients must be within 3 months of transplant
- Symptomatic with upper or lower respiratory tract symptoms and dosing within 6 days of symptom onset
- Chest X-ray with Radiologic Severity Index (RSI) score of 6 or less
- Pulse oximetry showing hemoglobin saturation of 93% or higher on room air
- Spirometry showing forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) of 70% or more of predicted value
- Adult aged 18 years or older
- For females: post-menopausal, surgically sterile, or using two effective birth control methods during the study and 30 days after
- Females must not be pregnant or nursing during the study and 30 days after; negative pregnancy test required
- For males: surgically sterile or using two effective birth control methods during the study and 30 days after
- Ability to understand and give informed consent
You will not qualify if you...
- Pulse oximetry hemoglobin saturation less than 93% on room air
- History of chronic lung diseases such as asthma, pulmonary fibrosis, COPD, pulmonary hypertension, or heart failure
- Treated for fungal, viral, or bacterial pneumonia in the last 30 days
- Exposure to any investigational drug within 30 days or 5 half-lives before screening
- Allogeneic stem cell transplant recipients with ISI of 3 or less
- Autologous stem cell transplant recipients more than 3 months after transplant
- Relapsed or refractory hematologic malignancy with life expectancy under 2 months
- Stem cell transplant recipients in pre-engraftment period
- Chest X-ray with RSI greater than 6
- Positive test for other respiratory viruses like influenza, SARS-CoV-2, adenovirus, or coronavirus within 7 days before screening
- Active bacteremia or fungemia not adequately treated within 7 days before screening
- Any condition that would prevent full participation or interfere with study evaluation
- Previous exposure to PUL-042 Inhalation Solution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
6
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Lineberger Cancer
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
9
OU Health Physicians - Infectious Disease Clinic
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
University of Texas MD Anderson MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Colin Broom, MD
CONTACT
B
Brenton Scott, Ph D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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