NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.

After being informed about the study and potential risks, all patient volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the patient qualifies for the study, they will be randomized in a double-blind manner in a 1:1 ratio to receive NasoVAX or placebo. On the same day of qualifying into the study, the patient will be administered the investigational drug (either NasoVAX or placebo).

The patient will return home for the remainder of the study. During this period, the patient will be monitored remotely by the study center for clinical status. The patient will also be contacted by study center personnel by telephone to ask about use of any medications and changes in health including information about any hospitalization.

Inclusion Criteria:

1. Able and willing to provide informed consent (Patients themselves must provide written informed consent before the performance of any study-related procedures, and surrogate consent by family members, designated legal representatives or caregivers will not be permitted).

2. Men and women 18 years of age and older

3. Early COVID-19, defined as one or more symptom(s) of fever (oral temperature ≥ 100.4 degrees F), cough, or shortness of breath, onset of these symptoms within 72 hours of screening, and confirmation of SARS-CoV-2 infection by a polymerase chain reaction (PCR)-based or rapid antigen diagnostic.

4. Resting SpO2 ≥ 96.0% on room air on two successive measurements

5. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause])

   • Negative urine pregnancy test at Screening
   • Willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last dose of study drug

6. For men with sexual partners of childbearing potential, willingness to practice a highly effective method of contraception, as defined above, for 45 days after the last dose of study drug

7. Ability and willingness to comply with all aspects of the study, including reliable internet access, through the entire study period

Exclusion Criteria:

1. Pregnant or lactating women or planning to conceive a child during the next 3 months

2. Resting respiratory rate >20 breaths/min on room air or resting pulse rate ≥ 125 beats per minute

3. A rapidly worsening course that in the opinion of the Investigator or treating medical practitioner would lead to hospitalization within the next 24-48 hours

4. Any chronic pulmonary disease, including chronic obstructive pulmonary disease and asthma, or other respiratory diseases that could exacerbate independent of COVID-19

5. The following risk factors for severe COVID-19 (Cohorts 1 and 2 only) (Centers for Disease Control 2020), which based on ongoing review of efficacy and safety data, the DMC may remove part or all of these risk factors if preliminary data show no signal for adverse or paradoxical effects:

   1. Severe obesity, defined as body mass index ≥ 40 kg/m2

   2. History of:

      • Severe cardiovascular disease, including but not limited to congestive heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, or pulmonary hypertension
      • Diabetes mellitus
      • Chronic or current vaping or cigarette smoking
      • Chronic kidney disease requiring dialysis
      • Chronic liver disease, including but not limited to chronic viral hepatitis, non-alcoholic steatohepatitis, or cirrhosis of any cause
      • Hemoglobin disorder, including sickle cell disease and thalassemia

6. History of Bell's Palsy

7. Nasal conditions that might affect the suitability of intranasal medication, such as a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or nasal surgery other than cosmetic rhinoplasty.

8. Use of hydroxychloroquine within the past 4 months, chloroquine with the past 9 months, or other investigational agents for COVID-19 within the past 30 days

9. History of conditions associated with immunocompromise, including but not limited to poorly controlled HIV, or treatments known to affect the immune system, including but not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites, cytotoxic drugs, radiation, immune-modulating biologics (including interleukin [IL]-6, IL-12, Janus kinase inhibitors or antagonists), and cancer treatments, within 30 days of Screening, or anticipated use within 6 months following participation in this study

10. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a patient's ability to give informed consent