Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV
Summary
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.
Detailed description
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.
Arms & interventions
- DrugPUL-042
Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution
- DrugPlacebo
Sterile Saline for Inhalation
Outcome measures
Primary
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
Secondary
Change from Pre-Treatment through 28 days
Time frame: 28 days
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)
Time frame: 28 days
Post-Treatment Viral RNA Titers (copies/mL)
Time frame: 28 days
Mortality (Incidence)
Time frame: 28 days
Oxygenation Requirements (Days)
Time frame: 28 days
Duration of ICU Care (Days)
Time frame: 28 days
Incidence of ICU Admission
Time frame: 28 days
Duration of hospitalization (Days)
Time frame: 28 days
Incidence of Hospitalization
Time frame: 28 days
Respiratory Symptom Scores
Time frame: 28 days
Incidence of Pneumonia (Clinical Diagnosis)
Time frame: 28 days
Adverse Events
Time frame: 28 days
Dose/Response
Time frame: 28 days
Eligibility criteria
Study locations (11)
City of Hope National Medical Center
Duarte, California, 91010
Northside Hospital
Atlanta, Georgia, 30342
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Minnesota
Minneapolis, Minnesota, 55455
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Lineberger Cancer
Chapel Hill, North Carolina, 27514
OU Health Physicians - Infectious Disease Clinic
Oklahoma City, Oklahoma, 73104
University of Texas MD Anderson MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109