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


Drug: PUL-042 Inhalation Solution

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

Drug: Placebo

Sterile saline for inhalation

Eligibility Criteria

Inclusion Criteria:

1. 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

2. Subjects must be 50 years or older if the exposure is due to cohabitation.

3. 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.

4. Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity
[FVC]) ≥70% of predicted value.

5. 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.

6. 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.

7. 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.

8. Ability to understand and give informed consent.

Exclusion Criteria:

1. Previous infection with SARS-CoV-2.

2. Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).

3. 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).

4. 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

5. Any condition which, in the opinion of the Principal Investigator, would prevent full

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

University of California Irvine
Orange, California, United States

Premier 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

Luminous Cinical Research- South Florida Urgent Care
Miami, Florida, United States

Entrust Clinical Research
Miami, Florida, United States

DBC Research
Tamarac, Florida, United States

Affinity Clinical Research, LLC
Tampa, Florida, United States

Clinical Research Atlanta
Stockbridge, Georgia, United States

Willis-Knighton Physcian Network
Bossier City, Louisiana, United States

Ascension St John
Bartlesville, Oklahoma, United States

Ascension St. John
Tulsa, Oklahoma, United States

Invesclinic US LLC
Edinburg, Texas, 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