study of the safety of therapeutic treatment with an immunomodulatory agent (n-803) in adults with covid-19

Conditions: COVID-19

Summary: this is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with covid-19. this clinical trial is designed to assess the safety and immunostimulatory activity of n-803.


Eligibility criteria:
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.