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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
Awards & highlights

PREVAIL Trial Summary

This trial will evaluate if TNX-102 SL 5.6 mg can help manage multi-site pain associated with Long COVID. The trial will last 14 weeks and compare TNX-102 SL 5.6 mg to a placebo.

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

PREVAIL Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Pain Score
Secondary outcome measures
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%
Ankle fracture
1%
Intraductal proliferative breast lesion
1%
Anxiety
1%
Hypoaesthesia oral
1%
Brain stem glioma
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

PREVAIL 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
29 Previous Clinical Trials
4,816 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

Frequently Asked Questions

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

Does this clinical trial have an upper age limit for participants?

"The age range for patients that this clinical trial is willing to accept begins at 18 years old and ends at 65 years old."

Answered by AI

Are there different sites where this trial is taking place?

"Picking from 31 available locations, patients can choose the site nearest them to help reduce travel demands."

Answered by AI

Are there any more patients needed to participate in this clinical trial?

"Yes, this trial is currently open for recruitment and has been since August 18th, 2022 according to the listing on clinicaltrials.gov."

Answered by AI

Could I be a candidate for this clinical research?

"470 individuals aged 18-65 who have had covid19 in the past 3 months and are experiencing new or worsening pain that began around the time of their initial infection are eligible for this study."

Answered by AI

How many individuals are currently signed up for this clinical trial?

"That is correct. The study, which was first announced on August 18th, 2020 is still recruiting the 470 patients it needs from 31 different locations."

Answered by AI

Has the FDA sanctioned TNX-102 SL for therapeutic use?

"There is some data supporting the safety of TNX-102 SL, but none indicating that it is an effective treatment. It received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Tonix Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection
2022. "A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05472090.
~24 spots leftby Apr 2025
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