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)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05472090 |
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Recruitment Status :
Completed
First Posted : July 25, 2022
Last Update Posted : September 6, 2023
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Sponsor:
Tonix Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection COVID-19 Long COVID Long Haul COVID | Drug: TNX-102 SL Drug: Placebo SL Tablet | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 63 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | August 18, 2022 |
| Actual Primary Completion Date : | July 12, 2023 |
| Actual Study Completion Date : | July 27, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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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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. |
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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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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. |
Primary Outcome Measures :
- Mean Pain Score [ Time Frame: Week 14 ]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.
Secondary Outcome Measures :
- Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance [ Time Frame: Week 14 ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05472090
Locations
| United States, Alabama | |
| Accel Research-Birmingham Clinical Research Unit | |
| Birmingham, Alabama, United States, 35216 | |
| United States, California | |
| Tonix Clinical Site | |
| Oceanside, California, United States, 92056 | |
| Tonix Clinical Site | |
| Santa Ana, California, United States, 92705 | |
| United States, Colorado | |
| Tonix Clinical Site | |
| Centennial, Colorado, United States, 80112 | |
| United States, Florida | |
| Tonix Clinical Site | |
| 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 | |
| United States, Georgia | |
| Tonix Clinical Site | |
| Alpharetta, Georgia, United States, 30022 | |
| Tonix Clinical Site | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Illinois | |
| Tonix Clinical Site | |
| Chicago, Illinois, United States, 60625 | |
| United States, Iowa | |
| Tonix Clinical Site | |
| Des Moines, Iowa, United States, 50265 | |
| Tonix Clinical Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Tonix Clinical Site | |
| Prairie Village, Kansas, United States, 66208 | |
| United States, Louisiana | |
| Tonix Clinical Site | |
| New Orleans, Louisiana, United States, 70124 | |
| Tonix Clinical Site | |
| Prairieville, Louisiana, United States, 70769 | |
| United States, Massachusetts | |
| Tonix Clinical Site | |
| Boston, Massachusetts, United States, 02115 | |
| Tonix Clinical Site | |
| Boston, Massachusetts, United States, 02131 | |
| Tonix Clinical Site | |
| Methuen, Massachusetts, United States, 01844 | |
| United States, Mississippi | |
| Tonix Clinical Site | |
| Gulfport, Mississippi, United States, 39503 | |
| United States, New Mexico | |
| Tonix Clinical Site | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Tonix Clinical Site | |
| New York, New York, United States, 10036 | |
| Tonix Clinical Site | |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Tonix Clinical Site | |
| Shelby, North Carolina, United States, 28150 | |
| United States, Ohio | |
| Tonix Clinical Site | |
| Columbus, Ohio, United States, 43215 | |
| Tonix Clinical Site | |
| Dayton, Ohio, United States, 45432 | |
| United States, Oklahoma | |
| Tonix Clinical Site | |
| Tulsa, Oklahoma, United States, 74133 | |
| United States, Texas | |
| Tonix Clinical Site | |
| Austin, Texas, United States, 78737 | |
| Tonix Clinical Site | |
| McKinney, Texas, United States, 75070 | |
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
| Study Director: | Herb Harris, MD, PhD | Tonix Pharmaceuticals |
| Responsible Party: | Tonix Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT05472090 |
| Other Study ID Numbers: |
TNX-CY-PA201 |
| First Posted: | July 25, 2022 Key Record Dates |
| Last Update Posted: | September 6, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Tonix Pharmaceuticals, Inc.:
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Multi-site pain Sleep disturbance PASC |
COVID-19 Long COVID Coronavirus infections |
Additional relevant MeSH terms:
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Infections Communicable Diseases COVID-19 Post-Acute COVID-19 Syndrome Disease Attributes Pathologic Processes Pneumonia, Viral Pneumonia Respiratory Tract Infections |
Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Post-Infectious Disorders Chronic Disease |