Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Principal investigator is leaving the institution.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NeoImmuneTech | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-I7 (Phase I) | Experimental |
|
|
| NT-I7 (Pilot) | Experimental |
|
|
| Placebo (Pilot) | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-I7 | Drug | Supplied by study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Percent change in absolute lymphocyte count (ALC) | From baseline to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in absolute lymphocyte count (ALC) | From baseline through Day 21 | |
| Change in SARS-CoV-2 viral load | -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva | From baseline to Day 7 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jian Campian, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
The clinicians, participants, and clinical research coordinators will be blinded
| Placebo |
| Drug |
Supplied by study |
|
| Blood for research purposes | Procedure | Prior to injection (Day 0), Day 7, and Day 14 |
|
| Blood for pharmacokinetic samples | Procedure | -Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21 |
|
| Nasopharyngeal, oropharyngeal, or saliva swab | Procedure | -Prior to study treatment, Day 4(optional), Day 7, and Day 14 |
|
| Blood for anti-drug antibody (ADA) | Procedure | 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 |
|
| Change in SARS-CoV-2 viral load | -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva | From baseline to Day 14 |
| COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement | From baseline, day 7, day 14, and day 21 |
| Time to resolution of COVID-19 symptoms | From baseline through Day 21 |
| Incidence of treatment-emergent adverse events | -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. | From baseline through Day 21 |
| Number of participants by PCR result status (positive or negative) | -If quantitative PCR is not available | -From baseline to Day 7 |
| Number of participants by PCR result status (positive or negative) | -If quantitative PCR is not available | From baseline to Day 14 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided