COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2
Brief summary
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.
Interventions
DRUGNT-I7
Supplied by study
DRUGPlacebo
Supplied by study
PROCEDUREBlood for research purposes
Prior to injection (Day 0), Day 7, and Day 14
PROCEDUREBlood for pharmacokinetic samples
-Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21
PROCEDURENasopharyngeal, oropharyngeal, or saliva swab
-Prior to study treatment, Day 4(optional), Day 7, and Day 14
PROCEDUREBlood for anti-drug antibody (ADA)
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
Sponsors
NeoImmuneTech
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The clinicians, participants, and clinical research coordinators will be blinded
Intervention model description
The study will open as a phase I study to test three different dose levels of NT-I7. Once a safe tolerated dose is established, the pilot portion of the study will be activated wherein participants will be randomized on a 1:1 basis to receive a single injection of NT-I7 (at the safe tolerated dose) or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Tested PCR positive for SARS-CoV-2by nasopharyngeal swab, oropharyngeal swab, or saliva. * Mild COVID-19, defined as WHO Ordinal Scale \<4 . * Respiratory rate \< 20 bpm, HR \< 90 bpm, and SpO2 \> 93% on room air at sea level. * Absolute lymphocyte count (ALC) \< 1500 cells/mm3 at the time of screening. * AST/ALT ≤ 3.0 x ULN, total bilirubin ≤ 1.5 x ULN (except if due to Gilbert's syndrome). -≥ 18 years of age. * First day of treatment must be no more than 10 days from onset of COVID-19 symptoms. * Must be willing to be closely monitored in the hospital or in an alternate setting (e.g. clinical trial unit) for at least the first 7 days (±2 days allowed) following NT-I7/placebo injection. * 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. * Patients with factors or concomitant illness associated with higher risk of mortality due to COVID-19 (such as older age, hypertension, diabetes, and/or COPD) are eligible. * Able to understand and willing to sign an IRB approved written informed consent document.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safe and tolerable dose of NT-I7 (Phase I only) | Completion of DLT assessment window of Phase I portion of study (estimated to be 8 months) | * 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 |
| Percent change in absolute lymphocyte count (ALC) | From baseline to Day 14 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SARS-CoV-2 viral load | From baseline to Day 7 | -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva |
| COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement | From baseline, day 7, day 14, and day 21 | — |
| Number of participants by PCR result status (positive or negative) | -From baseline to Day 7 | -If quantitative PCR is not available |
| Incidence of treatment-emergent adverse events | From baseline through Day 21 | -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 to resolution of COVID-19 symptoms | From baseline through Day 21 | — |
| Percent change in absolute lymphocyte count (ALC) | From baseline through Day 21 | — |
Outcome results
None listed