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PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

ConditionsHematologic MalignanciesHematopoietic Stem Cell Transplant (HSCT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPulmotect, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipients of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder.

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).

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.

Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.

Disqualifiers

Patients with a pulse oximetry of hemoglobin saturation less than 93% on room air.

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.

Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30 days.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PUL-042

    Drug

    Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution

  • Placebo

    Drug

    Sterile Saline for Inhalation

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PUL-042Experimental treatment 1 intervention
Group B: Sterile Saline for InhalationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pulmotect, Inc.

Lead sponsor

Cancer Prevention Research Institute of Texas

Collaborator

Source ClinicalTrials.gov
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