NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
Condition: Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections; Communicable Diseases; Infections
Intervention: NasoVAX; Placebo
Intervention description: NasoVAX consists of replication-deficient adenovirus vectors in suspension; Normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-Blind
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; SARS-CoV-2

Summary:

      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.
    

Eligibility criteria:

        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