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

Part of paid clinical trials in Duarte, California.

Sponsor
Pulmotect, Inc.
Study ID
NCT06665100
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hematologic Malignancies
  • Hematopoietic Stem Cell Transplant (HSCT)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PUL-042 — DRUG
    Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution
  • Placebo — DRUG
    Sterile Saline for Inhalation

Study Details

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.

Key Dates

Start date
Jun 27, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PUL-042
    PUL-042 Inhalation Solution
  • Placebo Comparator: Sterile Saline for Inhalation
    Placebo

Primary Outcome Measure

Efficacy of PUL-042 Inhalation Solution on Lower Respiratory Tract Complications (LRTC) [ Time Frame: 28 days ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Sanjeet Dadwal, MD
[email protected]
(855) 952-3335
Northside HospitalAtlantaGeorgia30342
Gowri Satyanarayana, MD
[email protected]
404-531-0044
Johns Hopkins HospitalBaltimoreMaryland21205
Maria Veronica Dioverti-Prono, MD
[email protected]
410-955-8964
Brigham and Women's HospitalBostonMassachusetts02115
Sophia Koo, MD
[email protected]
617-732-8881
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201
Joseph Uberti, MD, PhD
[email protected]
800-527-6266
University of MinnesotaMinneapolisMinnesota55455
Jo-Anne Young, MD
[email protected]
612-624-9996
John Theurer Cancer CenterHackensackNew Jersey07601
Michele Donato, MD
[email protected]
551-996-8297
Lineberger CancerChapel HillNorth Carolina27514
Paul Armistead, MD, PhD
[email protected]
(919) 843-6847
OU Health Physicians - Infectious Disease ClinicOklahoma CityOklahoma73104
Joseph Sassine, MD
[email protected]
(405) 271-6434
University of Texas MD Anderson MD Anderson Cancer CenterHoustonTexas77030
Amy Spallone, MD
[email protected]
713 792 2121
Fred Hutchinson Cancer CenterSeattleWashington98109
Michael Boeckh, MD, PhD
[email protected]
206-667-4411

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CANorthside Hospital· Atlanta, GAJohns Hopkins Hospital· Baltimore, MDBrigham and Women's Hospital· Boston, MABarbara Ann Karmanos Cancer Institute· Detroit, MIUniversity of Minnesota· Minneapolis, MN

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