The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

NCT04312997 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PUL-042-502
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 11

Brief Summary

Adults who have tested positive for SARS-CoV-2 infection and who may require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Worsening of COVID-19 Within 28 Days

  To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection, and 2) if receiving oxygen, should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs (Ordinal Scale for Clinical Improvement 4 or less) at the time of enrollment. The primary endpoint analysis is the evaluation of the number of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement. Higher values represent a worse outcome. The OSCI is a nine-point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

  28 days

Secondary Outcomes (7)

• Number of Participants With Positive SARS-CoV-2 Test Results at the End of Study

  28 days

• Number of Participants With Worsening of COVID-19 Over 14 Days

  14 days

• Time to COVID-19 Symptom Improvement: Respiratory Symptoms

  28 days

• Time to Resolution of COVID-19 Symptoms

  28 days

• Number of Participants Requiring ICU Admission

  28 days

Study Arms (2)

PUL-042 Inhalation Solution

EXPERIMENTAL

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

Drug: PUL-042 Inhalation Solution

Sterile saline for inhalation

PLACEBO COMPARATOR

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

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

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 a positive test for SARS-CoV-2.
• COVID-19 signs and symptoms such as (fever, cough, shortness of breath or fatigue) with onset within the 7 days prior to Screening
• Subjects should be Ordinal Scale for Clinical Improvement score of 4 or less.
• Subjects receiving oxygen should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs.
• Subjects can be receiving standard of care (SOC) for COVID-19, this includes marketed therapies or therapies with Emergency Use Authorization (EUA) for COVID-19 treatment.
• Subject's spirometry (FEV1 and forced vital capacity \[FVC\]) must be ≥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.
• Must have the ability to understand and give informed consent.

You may not qualify if:

• No documented infection with SARS-CoV-2.
• Patients who are in respiratory distress or require high flow oxygen, non-invasive ventilation or mechanical ventilation (Ordinal Scale for Clinical Improvement \>4) or with pulse oximetry less than 93% on oxygen with a flow rate of 3 liters per minute or less by nasal prongs at the time of screening.
• 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.
• Exposure to any investigational therapy (defined as any agent not currently marketed or without EUA) at the time of or within 30 days prior to the Screening Visit.
• Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of trial endpoints

Sponsors & Collaborators

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

Study Sites (11)

University of California Irvine

Orange, California, 92868, United States

Location

Premeir 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

DBC Research Corp.

Tamarac, Florida, 33321, United States

Location

Affinity Clinical Research, LLC

Tampa, Florida, 33612, United States

Location

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Ascension St. John

Bartlesville, Oklahoma, 74006, United States

Location

Ascension St. John

Tulsa, Oklahoma, 74104, 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: TREATMENT
• 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 16, 2020
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)