A Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Enhance Immune Clearance of SARS-CoV-2 (COVID-19)

Inclusion Criteria:

- Tested PCR positive for SARS-CoV-2by nasopharyngeal swab, oropharyngeal swab, or saliva..

- Absolute lymphocyte count (ALC) ≤ 1500 cells/mm3 at the time of diagnosis

- ≥ 18 years of age.

- Able to understand and willing to sign an IRB approved written informed consent document.

- Time of enrollment needs to be ≤ 10 days from COVID-19 symptom onset. Individuals of reproductive potential must agree to either abstinence or use of at least one study-approved form of contraception when engaging in sexual activities that can result in pregnancy from the time of screening through 60 days for female and 120 days for male after study agent administration. Acceptable forms of contraception for this study are male or female condoms, diaphragms or cervical caps with a spermicide, or non-hormonal intrauterine devices. Hormonal contraception methods are not acceptable during this protocol.

- Agrees to not participate in any other clinical trial for an investigational therapy through end of study visit.

Exclusion Criteria:

- Receiving any other investigational agents which may affect patient's lymphocyte counts. Note: There is no evidence that chloroquine or hydroxychloroquine could affect lymphocyte counts. Thus, chloroquine or hydroxychloroquine use is not an exclusion criteria for this study.

- Pregnant or breastfeeding women are excluded from this study because NT-I7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc

- Severe COVID-19 (defined as WHO Ordinal Scale ≥5).

- Patients transferred from ICU to the floor will not be eligible.

- COVID-19 symptoms for >10 days.

- Receipt of live attenuated vaccine within 30 days before the study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.