Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19

Inclusion Criteria:

1. Patients are 18-70 years of age;

2. Patients must have at least one of the following risk factors for developing severe COVID-19 disease:

   1. Age 50 to 70 years;
   2. Obesity (body mass index (BMI) of 30 or greater);
   3. Hypertension;
   4. Current smoker;
   5. Diabetes mellitus (Type 1 or type 2);
   6. Stable cardiac disease.
3. Experiencing symptoms of mild to moderate COVID-19 not requiring supplemental oxygen;
4. Having confirmed infection with SARS-CoV-2, defined as detection of SARS-CoV-2 from nasopharyngeal swab or lower respiratory tract specimen;
5. Karnofsky Performance Score ≥70%;
6. Enrolled within the first 4 days of onset of symptoms;
7. Able and willing to comply with the protocol for duration of the study, including 24 hour hospitalization for study drug administration and monitoring, and compliance with follow-up visit schedule;
8. Signed IRB approved informed consent.

Exclusion Criteria:

1. Patient is at high-risk for severe COVID-19 due to co-morbidities defined as:

   1. Underlying lung disease such as emphysema, chronic lung disease, COPD, asthma, chronic bronchiectasis or respiratory failure requiring baseline oxygen (O2) support;
   2. Immunocompromised host status due to cancer, transplant, or other causes of immunodeficiency;

   3. Immunosuppressive therapy, including but not limited to the following:

      • Corticosteroids (except topical corticosteroids);
      • Interleukin (IL)-6 or Tumor necrosis factor alpha (TNFα) blockade;
      • Other immunotherapies.

2. Patient with the following signs of abnormal organ or bone marrow function as defined below:

   • AST(SGOT) and/or ALT(SGPT) > 3 x upper limit of normal (ULN);
   • Serum (total) bilirubin > 1.5 x ULN;
   • Creatinine Clearance ≤ 30 mL/min (by Modification of Diet in Renal Disease (MDRD) formula);
   • Hemoglobin < 9 g/dL;
   • Thrombocytes ≤ 75.000/uL;
   • Absolute neutrophil count (ANC) ≤ 1.500/uL;
   • Prothrombin time (PT) or activated partial thromboplastin (aPTT) time >1.5 × ULN;
3. Patient has been admitted to the (ICU);
4. Patients with QT prolongation, history of "torsades de pointes" or ventricular arrhythmia (if they are scheduled to receive diphenhydramine);
5. Patient with a known history of allergic reactions to any constituent of the product, including a known history of allergic reactions to cellular products or DMSO;
6. Pregnant (positive pregnancy test) or breast-feeding female patients;
7. Women of childbearing potential who are sexually active and men who have sexual contact with a female of childbearing potential: not willing to use reliable methods of contraception (oral contraceptives, intrauterine device, hormone implants, contraceptive injection or abstinence) up to 90 days post injection of study medication;
8. Participation in other COVID-19 studies involving experimental treatments or vaccines for COVID-19. Participation in other observational studies could be allowed if they do not interfere with protocol compliance or blood draws;
9. Patients with a history or current evidence of alcohol or drug abuse or dependence, or recreational use of illicit drugs including use of medical marijuana;
10. Vulnerable populations such as those currently incarcerated or homeless;
11. Any other condition which in the opinion of the investigator makes the patient ineligible for participation in the study.