CovidResearchTrials by Shray Alag

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NT-I7Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)

Name (Synonyms) Correlation
drug438 Blood for anti-drug antibody (ADA) Wiki 1.00
drug440 Blood for research purposes Wiki 1.00
drug1844 Nasopharyngeal, oropharyngeal, or saliva swab Wiki 1.00
drug439 Blood for pharmacokinetic samples Wiki 1.00
drug1456 Intervention App Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D001523 Mental Disorders NIH 0.20
D013313 Stress Disorders, Post-Traumatic NIH 0.18
D004194 Disease NIH 0.17
D001008 Anxiety Disorders NIH 0.15

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase I and Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2

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.

NCT04498325 COVID-19 SARS-CoV-2 Drug: NT-I7 Drug: Placebo Procedure: Blood for research purposes Procedure: Blood for pharmacokinetic samples Procedure: Nasopharyngeal, oropharyngeal, or saliva swab Procedure: Blood for anti-drug antibody (ADA)

Primary Outcomes

Description: 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

Measure: Safe and tolerable dose of NT-I7 (Phase I only)

Time: Completion of DLT assessment window of Phase I portion of study (estimated to be 8 months)

Measure: Percent change in absolute lymphocyte count (ALC)

Time: From baseline to Day 14

Secondary Outcomes

Measure: Percent change in absolute lymphocyte count (ALC)

Time: From baseline through Day 21

Description: -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva

Measure: Change in SARS-CoV-2 viral load

Time: From baseline to Day 7

Description: -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva

Measure: Change in SARS-CoV-2 viral load

Time: From baseline to Day 14

Measure: COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement

Time: From baseline, day 7, day 14, and day 21

Measure: Time to resolution of COVID-19 symptoms

Time: From baseline through Day 21

Description: -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.

Measure: Incidence of treatment-emergent adverse events

Time: From baseline through Day 21

Description: -If quantitative PCR is not available

Measure: Number of participants by PCR result status (positive or negative)

Time: -From baseline to Day 7

Description: -If quantitative PCR is not available

Measure: Number of participants by PCR result status (positive or negative)

Time: From baseline to Day 14

No related HPO nodes (Using clinical trials)