Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

1. Acute febrile illness with temperature â?¥ 100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat) on Day 0 prior to dosing, <br/ >2. Positive serologic test for SARS-CoV-2 at Screening (this criterion only applies after approximately 402 subjects positive for SARS-CoV-2 serologic test are randomized, after which this criterion will apply to all remaining subjects), <br/ >3. Pregnant or breastfeeding, or intending to become pregnant or intending to father children starting from the Screening visit until the last dose, <br/ >4. Positive urine pregnancy test during screening or immediately prior to dosing, <br/ >5. Known history of uncontrolled HIV based on a CD4 count less than 200 cells/mm3 or a detectable viral load within 3 months prior to screening, <br/ >6. Is currently participating or has participated in a study with an investigational product within 30 days prior to Day 0 (documented receipt of placebo in a previous trial would be permissible for trial eligibility), <br/ >7. Previous or planned receipt of an investigational (including Emergency Use Authorization (EUA) or local equivalent authorization) or licensed vaccine for prevention or treatment of COVID-19, MERS or SARS (documented receipt of placebo in previous trial would be permissible for trial eligibility), <br/ >8. Immunosuppression as a result of underlying illness or treatment including: <br/ >a) Primary immunodeficiencies (conditions including hypothyroidism, Hashimotoâ??s thyroiditis and vitiligo are allowed), <br/ >b) Long term use (â?¥7 days) of oral or parenteral glucosteroids at a dose of â?¥20 mg/day of prednisone equivalent (use of inhaled, topical, nasal, otic, and ophthalmic corticosteroids are allowed) in the past 6 months, <br/ >c) Current or anticipated use of disease modifying doses of systemic anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease modifying drugs such as TNF- α inhibitors (e.g., infliximab, adalimumab or etanercept) or others, <br/ >d) History of solid organ or bone marrow transplantation, <br/ >e) History of or current receipt of any other clinically significant immunosuppressive drugs. <br/ >f) Diagnosis of an autoimmune disease that may jeopardize the safety of the subject or require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results. <br/ >9. Lack of acceptable sites for ID injection and EP considering the skin above the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: <br/ >a) Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site, <br/ >b) Implantable-Cardioverter-Defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist), <br/ >c) Any metal implants or implantable medical device within the electroporation site, <br/ >10. Blood donation or transfusion within 1 month prior to Day 0, <br/ >11. People who work remotely or in a socially distanced setting with minimal risk of exposure to SARS-CoV-2, <br/ >12. Prisoners or subjects who are compulsorily detained (involuntary incarceration), <br/ >13. Reported alcohol or substance abuse/dependence or illicit drug use (excluding marijuana use) within the prior 2 years, <b

1. Acute febrile illness with temperature â?¥ 100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat) on Day 0 prior to dosing, <br/ >2. Positive serologic test for SARS-CoV-2 at Screening (this criterion only applies after approximately 402 subjects positive for SARS-CoV-2 serologic test are randomized, after which this criterion will apply to all remaining subjects), <br/ >3. Pregnant or breastfeeding, or intending to become pregnant or intending to father children starting from the Screening visit until the last dose, <br/ >4. Positive urine pregnancy test during screening or immediately prior to dosing, <br/ >5. Known history of uncontrolled HIV based on a CD4 count less than 200 cells/mm3 or a detectable viral load within 3 months prior to screening, <br/ >6. Is currently participating or has participated in a study with an investigational product within 30 days prior to Day 0 (documented receipt of placebo in a previous trial would be permissible for trial eligibility), <br/ >7. Previous or planned receipt of an investigational (including Emergency Use Authorization (EUA) or local equivalent authorization) or licensed vaccine for prevention or treatment of COVID-19, MERS or SARS (documented receipt of placebo in previous trial would be permissible for trial eligibility), <br/ >8. Immunosuppression as a result of underlying illness or treatment including: <br/ >a) Primary immunodeficiencies (conditions including hypothyroidism, Hashimotoâ??s thyroiditis and vitiligo are allowed), <br/ >b) Long term use (â?¥7 days) of oral or parenteral glucosteroids at a dose of â?¥20 mg/day of prednisone equivalent (use of inhaled, topical, nasal, otic, and ophthalmic corticosteroids are allowed) in the past 6 months, <br/ >c) Current or anticipated use of disease modifying doses of systemic anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease modifying drugs such as TNF- α inhibitors (e.g., infliximab, adalimumab or etanercept) or others, <br/ >d) History of solid organ or bone marrow transplantation, <br/ >e) History of or current receipt of any other clinically significant immunosuppressive drugs. <br/ >f) Diagnosis of an autoimmune disease that may jeopardize the safety of the subject or require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results. <br/ >9. Lack of acceptable sites for ID injection and EP considering the skin above the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: <br/ >a) Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site, <br/ >b) Implantable-Cardioverter-Defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist), <br/ >c) Any metal implants or implantable medical device within the electroporation site, <br/ >10. Blood donation or transfusion within 1 month prior to Day 0, <br/ >11. People who work remotely or in a socially distanced setting with minimal risk of exposure to SARS-CoV-2, <br/ >12. Prisoners or subjects who are compulsorily detained (involuntary incarceration), <br/ >13. Reported alcohol or substance abuse/dependence or illicit drug use (excluding marijuana use) within the prior 2 years, <b