The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

NCT04313023 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PUL-042-501
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 15

Brief Summary

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy.

  To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 28 days from the start of experimental therapy. The OSCI to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. The minimum score is 0, maximum is 8. Higher values represent a worse outcome. OSCI Scale: 0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized \& requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7

  28 days

Secondary Outcomes (6)

• Percentage of SARS-CoV-2 Infections Through Day 29

  28 days

• Percentage of SARS-CoV-2 Infections Through Day 15

  14 days

• Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 14 Days From the Start of Experimental Therapy.

  14 days

• Number of Participants With ICU Admission

  28 days

• Number of Participants Requiring Mechanical Ventilation

  28 days

Study Arms (2)

PUL-042 Inhalation Solution

EXPERIMENTAL

PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10

Drug: PUL-042 Inhalation Solution

Sterile saline for inhalation

PLACEBO COMPARATOR

Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10

Drug: Placebo

Interventions

PUL-042 Inhalation Solution DRUG

20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution

PUL-042 Inhalation Solution

Placebo DRUG

Sterile saline for inhalation

Sterile saline for inhalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have recent exposure to SARS-CoV-2 (such as repeated or extensive exposure to an infected individual(s) or cohabiting with a SARS-CoV-2 positive individual).
• Subjects must be 50 years or older if the exposure is due to cohabitation.
• Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis (Ordinal Scale of Clinical Improvement score of 0) with a SARS-CoV-2 infection symptom score (fever, cough, shortness of breath, and fatigue) of 0 in each category.
• Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity \[FVC\]) ≥70% of predicted value.
• If female, the subject must be surgically sterile or ≥ 1 year postmenopausal. If of child-bearing potential (including being \< 1years postmenopausal) and, if participating in sexual activity that may lead to pregnancy, the subject agrees to use an effective dual method of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study.
• If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.
• If male, must be surgically sterile or, if not surgically sterile and if participating in sexual activities that may lead to pregnancy, be willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study.
• Ability to understand and give informed consent.

You may not qualify if:

• Previous infection with SARS-CoV-2.
• Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).
• A SARS-CoV-2 infection symptom score greater than 0 in any of the 4 catergories (fever, cough, shortness of breath or fatigue) at the time of screening (Ordinal Scale for Clinical Improvement score of 0).
• 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.
• Any condition which, in the opinion of the Principal Investigator, would prevent full participation

Sponsors & Collaborators

• Pulmotect, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (15)

University of California Irvine

Orange, California, 92868, United States

Location

Premier Urgent Care of California

San Bernardino, California, 92404, United States

Location

Clinical Research of South Florida Alliance for Multispecialty Research

Coral Gables, Florida, 33134, United States

Location

Invesclinic US LLC

Fort Lauderdale, Florida, 33308, United States

Location

Luminous Cinical Research- South Florida Urgent Care

Miami, Florida, 33136, United States

Location

Entrust Clinical Research

Miami, Florida, 33156, United States

Location

DBC Research

Tamarac, Florida, 33321, United States

Location

Affinity Clinical Research, LLC

Tampa, Florida, 33612, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Willis-Knighton Physcian Network

Bossier City, Louisiana, 71111, United States

Location

Ascension St John

Bartlesville, Oklahoma, 74006, United States

Location

Ascension St. John

Tulsa, Oklahoma, 74104, United States

Location

Invesclinic US LLC

Edinburg, Texas, 78539, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Brenton Scott, President & COO
• Organization: Pulmotect, Inc.

bscott@pulmotect.com

713-579-9226

Study Officials

• Colin Broom, MD

  Pulmotect, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: June 9, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)