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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
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 • NCT0201523413%
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
4,994 Total Patients Enrolled
Herb Harris, MD, PhDStudy DirectorTonix Pharmaceuticals
1 Previous Clinical Trials
685 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are male or female, 18 to 65 years of age, inclusive.You have a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.You have had pain for at least 3 months, but not more than 18 months, that started or got worse after you had COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: TNX-102 SL Tablet, 5.6 mg
- Group 2: Placebo SL Tablet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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