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.
A total of up to 100 participants will be enrolled in this research study, at up to 15 centers. Participants in the study will receive either PUL-042 or a placebo (an inactive agent that appears identical to PUL-042). Patients will be randomized 1:1 for PUL-042 or placebo. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGNorthside Hospital
Atlanta, Georgia, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGBarbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGJohn Theurer Cancer Center
Hackensack, New Jersey, United States
RECRUITINGLineberger Cancer
Chapel Hill, North Carolina, United States
NOT_YET_RECRUITINGOU Health Physicians - Infectious Disease Clinic
Oklahoma City, Oklahoma, United States
RECRUITINGUniversity of Texas MD Anderson MD Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 1 more locations
Efficacy of PUL-042 Inhalation Solution on Lower Respiratory Tract Complications (LRTC)
Determine efficacy of PUL-042 Inhalation Solution on lower respiratory tract complications (LRTC) using the peak post-treatment radiologic severity index (RSI) score in subjects with hematologic malignancies (HM \[lymphoma, multiple myeloma and leukemia\]) and hematopoietic stem cell transplant (HSCT) recipients with documented parainfluenza virus (PIV), human metapneumovirus (hMPV), or respiratory syncytial virus (RSV) infection. The RSI is a quantitative score based on the presence of pulmonary infiltrates in three zones in both lungs, a total of six zones. Normal in all zones would be a score of zero with a maximum score of 72, which represents total consolidation in all six zones.
Time frame: 28 days
Change from Pre-Treatment through 28 days
To determine the difference in the change from pre-treatment to peak post-treatment RSI score through 28 days. The RSI is a quantitative score based on the presence of pulmonary infiltrates in three zones in both lungs, a total of six zones. Normal in all zones would be a score of zero with a maximum score of 72, which represents total consolidation in all six zones.
Time frame: 28 days
Proportion of Subjects Positive for Each Virus at Each Sampling Timepoint
To determine the effect of PUL-042 through 28 days for the proportion of subjects positive for each virus at each sampling timepoint.
Time frame: 28 days
Change in Viral RNA Shedding Relative to Baseline (copies/mL)
To determine the effect of PUL-042 through 28 days for the change in viral RNA shedding relative to baseline (copies/mL).
Time frame: 28 days
Post-Treatment Viral RNA Titers (copies/mL)
To determine the effect of PUL-042 through 28 days for post-treatment viral RNA titers (copies/mL).
Time frame: 28 days
Mortality (Incidence)
To determine the effect of PUL-042 through 28 days for mortality (incidence).
Time frame: 28 days
Oxygenation Requirements (Days)
The effect of PUL-042 through 28 days on the number of days on supplemental oxygen for each subject.
Time frame: 28 days
Duration of ICU Care (Days)
To determine the effect of PUL-042 through 28 days for the duration of ICU care (days).
Time frame: 28 days
Incidence of ICU Admission
To determine the effect of PUL-042 through 28 days for the incidence of ICU admission.
Time frame: 28 days
Duration of hospitalization (Days)
To determine the effect of PUL-042 through 28 days for the duration of hospitalization (days).
Time frame: 28 days
Incidence of Hospitalization
To determine the effect of PUL-042 through 28 days for the incidence of hospitalization.
Time frame: 28 days
Respiratory Symptom Scores
To determine the effect of PUL-042 through 28 days for respiratory symptom scores (Patient reported symptoms of cough, shortness of breath, respiratory symptoms \[cough + shortness of breath\], sputum production and chest pain will each be recorded on a scale of 0 to 3 \[0=absent,1= mild, 2= moderate 3= severe\]).
Time frame: 28 days
Incidence of Pneumonia (Clinical Diagnosis)
To determine the effect of PUL-042 through 28 days (clinical diagnosis).
Time frame: 28 days
Adverse Events
To evaluate the incidence and severity of treatment emergent adverse events.
Time frame: 28 days
Dose/Response
The efficacy of the 50mcg and 70mcg dose levels relative to placebo on peak RSI and change from baseline in RSI will be calculated and statistical analysis of any difference performed. The RSI is a quantitative score based on the presence of pulmonary infiltrates in three zones in both lungs, a total of six zones. Normal in all zones would be a score of zero with a maximum score of 72, which represents total consolidation in all six zones.
Time frame: 28 days
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