The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
Condition: COVID-19
MeSH terms: COVID-19
Intervention: PUL-042 Inhalation Solution; Placebo
Intervention description: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042); Sterile saline for inhalation
Intervention MeSH terms: Pam2CSK4 acetate and ODN M362 combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

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