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
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
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.