- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05472090
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 (PREVAIL)
September 5, 2023 updated by: Tonix Pharmaceuticals, Inc.
A Phase 2, 14-week Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Multisite Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Program Manager
- Phone Number: 212-980-9155
- Email: megha.tevar@tonixpharma.com
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35216
- Accel Research-Birmingham Clinical Research Unit
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California
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Oceanside, California, United States, 92056
- Tonix Clinical Site
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Santa Ana, California, United States, 92705
- Tonix Clinical Site
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Colorado
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Centennial, Colorado, United States, 80112
- Tonix Clinical Site
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Florida
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Aventura, Florida, United States, 33180
- Tonix Clinical Site
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Fort Myers, Florida, United States, 33912
- Tonix Clinical Site
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Orlando, Florida, United States, 32801
- Tonix Clinical Site
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Saint Petersburg, Florida, United States, 33709
- Tonix Clinical Site
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Georgia
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Alpharetta, Georgia, United States, 30022
- Tonix Clinical Site
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Atlanta, Georgia, United States, 30329
- Tonix Clinical Site
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Illinois
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Chicago, Illinois, United States, 60625
- Tonix Clinical Site
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Iowa
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Des Moines, Iowa, United States, 50265
- Tonix Clinical Site
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Iowa City, Iowa, United States, 52242
- Tonix Clinical Site
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Kansas
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Prairie Village, Kansas, United States, 66208
- Tonix Clinical Site
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Louisiana
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New Orleans, Louisiana, United States, 70124
- Tonix Clinical Site
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Prairieville, Louisiana, United States, 70769
- Tonix Clinical Site
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Tonix Clinical Site
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Boston, Massachusetts, United States, 02115
- Tonix Clinical Site
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Methuen, Massachusetts, United States, 01844
- Tonix Clinical Site
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Mississippi
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Gulfport, Mississippi, United States, 39503
- Tonix Clinical Site
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Tonix Clinical Site
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New York
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New York, New York, United States, 10036
- Tonix Clinical Site
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Williamsville, New York, United States, 14221
- Tonix Clinical Site
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North Carolina
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Shelby, North Carolina, United States, 28150
- Tonix Clinical Site
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Ohio
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Columbus, Ohio, United States, 43215
- Tonix Clinical Site
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Dayton, Ohio, United States, 45432
- Tonix Clinical Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74133
- Tonix Clinical Site
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Texas
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Austin, Texas, United States, 78737
- Tonix Clinical Site
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McKinney, Texas, United States, 75070
- Tonix Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Major Inclusion Criteria:
- The patient is male or female, 18 to 65 years of age, inclusive.
- The patient has 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.
- The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.
Major Exclusion Criteria:
- The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
- The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo SL Tablet
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.
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Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks.
At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
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Experimental: TNX-102 SL Tablet, 5.6 mg
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.
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Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks.
At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Pain Score
Time Frame: Week 14
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Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint.
Scores range from 0 to 10 where a higher score means worse outcome.
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Week 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance
Time Frame: Week 14
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Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance at the Week 14 endpoint.
This form consists of 8 items in a 1-5 Likert scale.
A higher score means a worse outcome.
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Week 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Herb Harris, MD, PhD, Tonix Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2022
Primary Completion (Actual)
July 12, 2023
Study Completion (Actual)
July 27, 2023
Study Registration Dates
First Submitted
July 21, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Estimated)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Infections
- Communicable Diseases
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- TNX-CY-PA201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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