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Cytokine

Double-Blind NT-I7 for COVID-19

Phase 1
Waitlist Available
Research Sponsored by NeoImmuneTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 days
Awards & highlights

Study Summary

This trial is studying a vaccine to see if it is safe and if it can help the body create immunity against the virus that causes COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
Secondary outcome measures
Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NT-I7Experimental Treatment1 Intervention
NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.

Find a Location

Who is running the clinical trial?

NeoImmuneTechLead Sponsor
10 Previous Clinical Trials
500 Total Patients Enrolled
University of NebraskaOTHER
539 Previous Clinical Trials
1,144,727 Total Patients Enrolled
4 Trials studying COVID-19
849 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,462 Total Patients Enrolled
78 Trials studying COVID-19
292,201 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any limits as to how many people can take part in this experiment?

"Affirmative. Clinicaltrials.gov contains evidence that this research trial, initially posted on November 27th 2020, is in search for 30 patients from 2 different sites."

Answered by AI

Is geriatric recruitment being considered for this experiment?

"The eligibility requirements for this research project set the age range from 19 to 75. For minors under 18, there are 137 trials available and 910 options exist for those aged 65 or above."

Answered by AI

Is there a chance I could become involved in this experiment?

"This study is enrolling 30 individuals with COVID-19 who are aged between 19 and 75. In order to be eligible, applicants must abide by the following criteria: not partake in any other clinical trial for an investigational therapy within a month of applying; oxygen saturation exceeding 93% at rest; heart rate no more than 100 beats per minute when stationary; respiration rate beneath 20 breaths per minute without exhibiting respiratory distress."

Answered by AI

What potential risks have been identified with the use of Double-Blind NT-I7?

"Given the Phase 1 nature of this trial, our team at Power estimated that Double-Blind NT-I7 is relatively low risk with a rating of 1. This indicates minimal clinical data backing safety and efficacy claims."

Answered by AI

Are there any prior experiments with Double-Blind NT-I7 that have been conducted?

"In 2018, Double-Blind NT-I7 was initially studied at UCSF Comprehensive Cancer Center. Since then, 1 trial has been completed with 11 additional studies actively recruiting patients. These active investigations are largely based in Bethesda, Maryland."

Answered by AI

Is it possible for individuals to enroll in this experiment at present?

"Based on information available from clinicaltrials.gov, this medical trial is currently open for enrollment - it was first posted on the 27th of November 2020 and has since been updated as recently as September 26th 2022."

Answered by AI

Has this therapeutic research been previously attempted before?

"Currently, 11 different clinical trials for Double-Blind NT-I7 are open in 39 cities across four countries. NeoImmuneTech initiated the first trial of its kind back in 2018 with 12 participants; it successfully completed Phase 1 drug approval and has since concluded."

Answered by AI
~2 spots leftby Apr 2025