Lymphopenia is common in patients with COVID-19 and is associated with worse clinical outcomes. NT-I7 is a long-acting human interleukin-7 (IL-7) that has been shown to increase absolute lymphocyte count (ALC) and CD4+ and CD8+ T cell counts with a well-tolerated safety profile in humans. In this study, patients who have tested positive for SARS-CoV-2 by PCR testing without severe disease and with ALC \<1500 cells/mm3 will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Supplied by study
Supplied by study
Prior to injection (Day 0), Day 7, and Day 14
Safe and tolerable dose of NT-I7 (Phase I only)
* The safe tolerated dose is defined as the dose level immediately below the dose level at which 1 patient of a cohort of 3 patients experiences dose-limiting toxicity within 14 days after administration of NT-I7 * Dose limiting toxicities (DLT) are defined as: * A serious adverse event that is at least possibly related to NT-I7 * A grade 3 or higher adverse event that is at least possibly related to NT-I7 (excluding injection site swelling, irritation or discomfort) * A clinically significant lab abnormality that is at least possibly related to NT-I7
Time frame: Completion of DLT assessment window of Phase I portion of study (estimated to be 8 months)
Percent change in absolute lymphocyte count (ALC)
Time frame: From baseline to Day 14
Percent change in absolute lymphocyte count (ALC)
Time frame: From baseline through Day 21
Change in SARS-CoV-2 viral load
-Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva
Time frame: From baseline to Day 7
Change in SARS-CoV-2 viral load
-Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva
Time frame: From baseline to Day 14
COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement
Time frame: From baseline, day 7, day 14, and day 21
Time to resolution of COVID-19 symptoms
Time frame: From baseline through Day 21
Incidence of treatment-emergent adverse events
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-Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21
-Prior to study treatment, Day 4(optional), Day 7, and Day 14
Baseline, Day 7, Day 14, Day 21, Day 60, and Day 90. Participants with ADA positivity on Day 90 will be monitored every 90 days until antibody level returns to baseline
-A treatment emergent adverse event (TEAE) is defined as any event that begins or worsens on or after date of first dose of study treatment.
Time frame: From baseline through Day 21
Number of participants by PCR result status (positive or negative)
-If quantitative PCR is not available
Time frame: -From baseline to Day 7
Number of participants by PCR result status (positive or negative)
-If quantitative PCR is not available
Time frame: From baseline to Day 14