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Virus Therapy

Cohort 1 for Delayed-type Hypersensitivity Reactions (COVID-19 DTH Trial)

Phase 1
Waitlist Available
Research Sponsored by Tonix Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline visit
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 hours post skin test administration
Awards & highlights

Summary

This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.

Eligible Conditions
  • Delayed-type Hypersensitivity Reactions

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 hours post skin test administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 hours post skin test administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cohort 1Experimental Treatment5 Interventions
Healthy uninfected/unexposed subjects to SARS-CoV-2
Group II: Cohort 2Active Control5 Interventions
Subjects who have recovered from SARS-CoV-2 infection
Group III: Cohort 3Placebo Group5 Interventions
Subjects who have received a complete SARS-CoV-2 vaccine course
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CANDIN
2015
Completed Phase 2
~250
Diluent
2006
Completed Phase 3
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
73,752 Total Patients Enrolled
Tonix Pharmaceuticals, Inc.Lead Sponsor
29 Previous Clinical Trials
4,787 Total Patients Enrolled
Herb Harris, MDStudy DirectorTonix Pharmaceuticals
~25 spots leftby Sep 2025
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