It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival.
Several publications have suggested a potential role of NK cells, an essential part of the early innate response system, in the management of viral infections like COVID-19. Clinical data has shown that COVID-19 disease severity is correlated with a reduction in the number of NK cells, exhaustion of NK cells and the lack of certain mature, potent NK cell phenotypes. The power of NK cells to fight various other viral infections, such as caused by CMV, HBV and hepatitis C virus (HCV), influenza virus and human immunodeficiency virus (HIV) have been well described, with a durable change in the NK cell profile towards those more mature and potent phenotypes in recovered patients. In view of the lack of (functional) NK cells in patients with COVID-19, adoptive NK cell therapy with KDS-1000 cells may improve survival and reduce rates of disease progression from SARS-CoV-2 infection. Adoptive transfer of expanded NK cells (KDS-1000) early in the course of disease may augment innate immunity, thereby limiting disease progression and could confer a survival benefit to patients infected with SARS-CoV-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Non-randomized part of study: * At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals. Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts): * Cohort 1: Low Dose, 2x10E8 cells/dose * Cohort 2: High Dose, 1x10E9 cells/dose
0.9% Normal Saline
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of adverse events (AE)
Rate and severity of AE.
Time frame: 28 Days
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by COVID-19 specific questionnaire.
Improvement in COVID-19 disease symptoms/progression of disease.
Time frame: 90 Days
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by measurement of SARS-CoV-2 clearance.
Determined by real time reverse transcription polymerase chain reaction (rRT-PCR).
Time frame: 28 days
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of AE.
Rate and severity of AE.
Time frame: 90 Days
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