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

NCT ID: NCT04312997

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2021-07-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PUL-042 Inhalation Solution

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

Group Type: EXPERIMENTAL

PUL-042 Inhalation Solution

Intervention Type: DRUG

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

Sterile saline for inhalation

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile saline for inhalation

Interventions

PUL-042 Inhalation Solution

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

Intervention Type: DRUG

Placebo

Sterile saline for inhalation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects must have a positive test for SARS-CoV-2.

2. COVID-19 signs and symptoms such as (fever, cough, shortness of breath or fatigue) with onset within the 7 days prior to Screening

3. Subjects should be Ordinal Scale for Clinical Improvement score of 4 or less.

4. Subjects receiving oxygen should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs.

5. 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.

6. Subject's spirometry (FEV1 and forced vital capacity [FVC]) must be ≥70% of predicted value.

7. 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.

8. 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.

9. 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.

10. Must have the ability to understand and give informed consent.

Exclusion Criteria

1. No documented infection with SARS-CoV-2.

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.

3. 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.

4. 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.

5. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Pulmotect, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Broom, MD

Role: STUDY_DIRECTOR

Pulmotect, Inc.

Locations

University of California Irvine

Orange, California, United States

Premeir Urgent Care of California

San Bernardino, California, United States

Clinical Research of South Florida Alliance for Multispecialty Research

Coral Gables, Florida, United States

Invesclinic US LLC

Fort Lauderdale, Florida, United States

DBC Research Corp.

Tamarac, Florida, United States

Affinity Clinical Research, LLC

Tampa, Florida, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Ascension St. John

Bartlesville, Oklahoma, United States

Ascension St. John

Tulsa, Oklahoma, United States

MD Anderson Cancer Center

Houston, Texas, United States

Next Level Urgent Care

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PUL-042-502

Identifier Type: -

Identifier Source: org_study_id