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
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
individual).
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
failure.
5. Any condition which, in the opinion of the Principal Investigator, would prevent full
participation
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.