Official Title
A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
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


Drug: PUL-042 Inhalation Solution

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

Drug: Placebo

Sterile saline for inhalation

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

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

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

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

Colin Broom, MD, Study Director
Pulmotect, Inc.

United States Department of Defense
NCT Number
MeSH Terms
Pam2CSK4 acetate and ODN M362 combination