The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
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) PUL-042 Inhalation Solution; Sterile saline for inhalation
Intervention MeSH terms: Pam2CSK4 acetate and ODN M362 combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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
             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