A Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Enhance Immune Clearance of SARS-CoV-2 (COVID-19)

COVID-19 Clinical Trial

Official title:

A Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Enhance Immune Clearance of SARS-CoV-2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04380948
• Other study ID #: 04-20-20-Campian
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 31, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: Jian Campian, M.D., Ph.D.
• Phone: 314-362-5677
• Email: campian.jian[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, patients who have tested positive for SARS-CoV-2 by PCR testing without severe disease will be randomized on a 2:1 basis to receive a single injection of NT-I7 or placebo. All participants will receive best supportive care in addition to study treatment. The investigators hypothesize that NT-I7 can increase absolute lymphocyte count (ALC), thus potentially improve immune response to enhance viral clearance, thereby reducing duration of symptoms, minimizing contagiousness and preventing progression of severity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tested PCR positive for SARS-CoV-2by nasopharyngeal swab, oropharyngeal swab, or saliva..

• Absolute lymphocyte count (ALC) = 1500 cells/mm3 at the time of diagnosis

• = 18 years of age.

• Able to understand and willing to sign an IRB approved written informed consent document.

• Time of enrollment needs to be = 10 days from COVID-19 symptom onset. 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. Hormonal contraception methods are not acceptable during this protocol.

• Agrees to not participate in any other clinical trial for an investigational therapy through end of study visit.

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 exclusion criteria for this study.

• Pregnant or breastfeeding women are excluded from this study because NT-I7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc

• Severe COVID-19 (defined as WHO Ordinal Scale =5).

• Patients transferred from ICU to the floor will not be eligible.

• COVID-19 symptoms for >10 days.

• Receipt of live attenuated vaccine within 30 days before the study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• NT-17
Will be administered on Day 0

Drug:
• Placebo
Will be administered on Day 0

Other:
• Supportive care
Patients should receive full supportive care, including but not limited to intravenous fluids, transfusions of blood and blood products, antibiotics, antivirals, antibacterial agents, and antiemetics, when appropriate at the discretion of the treating clinician. Growth factors are permitted if clinically indicated, but should not be used prophylactically.

Procedure:
• Peripheral blood draw
-Baseline, Day 7 post study treatment, and Day 14 post study treatment

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in absolute lymphocyte count (ALC)		From baseline to Day 14
Secondary	Change in absolute lymphocyte count (ALC)		From baseline through 3 weeks post-treatment
Secondary	Change in SARS-CoV-2 viral load	-From nasopharyngeal swab, oropharyngeal swab or saliva	From baseline to Day 7
Secondary	Change in SARS-CoV-2 viral load	-From nasopharyngeal swab, oropharyngeal swab or saliva	From baseline to Day 14
Secondary	Time to resolution of COVID-19 symptoms		From baseline to Day 14
Secondary	Incidence of treatment-emergent adverse events		From baseline through 3 weeks post-treatment
Secondary	COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement		From baseline, Day 7, and Day 14

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine