Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19

Inclusion Criteria 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen \< 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp). 4. Has a confirmed NEW score of 0-5. 5. Has at least one of the following high-risk factors associated with a higher risk of COVID-19 progression: 1. Age ≥ 60 years. 2. Hypertension currently managed by at least 1 antihypertensive medication. 3. Type 1 or 2 diabetes. 4. Chronic obstructive pulmonary disease (COPD) diagnosed per medical history. 6. Adequate respiratory and heart function, evidenced by the following laboratory results: 1. Respiratory rate (RR) \< 20 breaths per minute (bpm). 2. Heart rate (HR) \< 90 beats per minute (bpm). 3. Arterial oxygen saturation (SaO2) \> 93% on room air. 7. Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol. 8. Ability to participate in required study visits and participate in adequate follow-up, as required by this protocol. 9. Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of N-803. Non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of N-803. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence. Exclusion Criteria: 1. Shortness of breath or hypoxia defined by a ratio of partial pressure of arterial oxygen to the percentage of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or signs of serious lower airway disease. 2. Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen. 3. Inflammatory markers (C-reactive protein \[CRP\], lactate dehydrogenase \[LDH\], d-dimer, ferritin, and IL-6) \> 1.5 × upper limit of normal (ULN). 4. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 5. Pregnant and nursing women. A negative serum or urine pregnancy test during screening prior to the first dose must be documented before N-803 is administered to a female subject of child-bearing potential.