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)

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
• Conditions: COVID-19; Long COVID; Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection; Long Haul COVID
• Intervention / Treatment: Drug: TNX-102 SL; Drug: Placebo SL Tablet

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Accel Research-Birmingham Clinical Research Unit
  • California
    • Oceanside, California, United States, 92056
      • Tonix Clinical Site
    • Santa Ana, California, United States, 92705
      • Tonix Clinical Site
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Tonix Clinical Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Tonix Clinical Site
    • Fort Myers, Florida, United States, 33912
      • Tonix Clinical Site
    • Orlando, Florida, United States, 32801
      • Tonix Clinical Site
    • Saint Petersburg, Florida, United States, 33709
      • Tonix Clinical Site
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Tonix Clinical Site
    • Atlanta, Georgia, United States, 30329
      • Tonix Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Tonix Clinical Site
  • Iowa
    • Des Moines, Iowa, United States, 50265
      • Tonix Clinical Site
    • Iowa City, Iowa, United States, 52242
      • Tonix Clinical Site
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Tonix Clinical Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • Tonix Clinical Site
    • Prairieville, Louisiana, United States, 70769
      • Tonix Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Tonix Clinical Site
    • Boston, Massachusetts, United States, 02115
      • Tonix Clinical Site
    • Methuen, Massachusetts, United States, 01844
      • Tonix Clinical Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Tonix Clinical Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Tonix Clinical Site
  • New York
    • New York, New York, United States, 10036
      • Tonix Clinical Site
    • Williamsville, New York, United States, 14221
      • Tonix Clinical Site
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Tonix Clinical Site
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Tonix Clinical Site
    • Dayton, Ohio, United States, 45432
      • Tonix Clinical Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Tonix Clinical Site
  • Texas
    • Austin, Texas, United States, 78737
      • Tonix Clinical Site
    • McKinney, Texas, United States, 75070
      • Tonix Clinical Site

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Placebo SL Tablet; 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.
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.	Drug: TNX-102 SL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Diary Pain NRS	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.	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Diary Sleep Quality NRS	Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.	Week 14
PROMIS Fatigue -Short Form 8a	Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.	Week 14
PROMIS Cognitive Function - Abilities-Short Form 8a	Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.	Week 14

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Study Director: Herb Harris, MD, PhD, Tonix Pharmaceuticals

Study record dates

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): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Long COVID; Sleep disturbance; PASC; Coronavirus infections; Multi-site pain
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome; Infections; Communicable Diseases
• 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