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TNX-102 SL for Post-COVID Syndrome (PREVAIL Trial)

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14

Summary

This trial tests a bedtime medication called TNX-102 SL for people with Long COVID who have widespread pain. The medication aims to reduce pain by working in the brain.

Eligible Conditions
  • Post-COVID Syndrome
  • Coronavirus
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Pain Score
Secondary study objectives
Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance

Side effects data

From 2015 Phase 3 trial • 158 Patients • NCT02015234
13%
Sinusitis
10%
Fatigue
8%
Upper respiratory tract infection
5%
Constipation
5%
Somnolence
5%
Paraesthesia
3%
Glossodynia
1%
Anxiety
1%
Intraductal proliferative breast lesion
1%
Ankle fracture
1%
Brain stem glioma
1%
Hypoaesthesia oral
1%
Abdominal hernia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - TNX-102 SL 2.8 mg
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TNX-102 SL Tablet, 5.6 mgExperimental Treatment1 Intervention
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
Group II: Placebo SL TabletPlacebo Group1 Intervention
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TNX-102 SL
2019
Completed Phase 3
~1660

Find a Location

Who is running the clinical trial?

Tonix Pharmaceuticals, Inc.Lead Sponsor
30 Previous Clinical Trials
4,913 Total Patients Enrolled
Herb Harris, MD, PhDStudy DirectorTonix Pharmaceuticals
1 Previous Clinical Trials
685 Total Patients Enrolled

Media Library

Placebo SL Tablet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05472090 — Phase 2
Post-COVID Syndrome Research Study Groups: TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet
Post-COVID Syndrome Clinical Trial 2023: Placebo SL Tablet Highlights & Side Effects. Trial Name: NCT05472090 — Phase 2
Placebo SL Tablet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472090 — Phase 2
~19 spots leftby Dec 2025
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