🏛️ Verified NIH Record • Updated 2026-08-03

PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) (NCT06665100)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Pulmotect, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (15 items).

Location: City of Hope National Medical Center — Duarte, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Subjects will be excluded if they fulfill any of the following exclusion criteria:
  • 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.
  • Allogeneic HSCT recipients with an ISI of 3 or less.
  • Autologous HSCT recipients more than 3 months after the transplant procedure.
  • Patients with a relapsed and/or refractory underlying hematologic malignancy with a life expectancy of less than 2 months.
  • HSCT recipients in the pre-engraftment period.
  • Chest X-ray with an RSI of \>6.
  • 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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (12 Sites)

  • City of Hope National Medical Center — Duarte, California
  • Northside Hospital — Atlanta, Georgia
  • Johns Hopkins Hospital — Baltimore, Maryland
  • Brigham and Women's Hospital — Boston, Massachusetts
  • Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
  • University of Minnesota — Minneapolis, Minnesota
  • John Theurer Cancer Center — Hackensack, New Jersey
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • Lineberger Cancer — Chapel Hill, North Carolina
  • OU Health Physicians - Infectious Disease Clinic — Oklahoma City, Oklahoma
  • University of Texas MD Anderson MD Anderson Cancer Center — Houston, Texas
  • Fred Hutchinson Cancer Center — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (484) 354-0615

Email: cbroom@pulmotect.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗