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Trial record 1 of 1 for:    NCT05472090
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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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ClinicalTrials.gov Identifier: NCT05472090
Recruitment Status : Recruiting
First Posted : July 25, 2022
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 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
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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.
Contacts and Locations
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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


Contacts
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Contact: Clinical Program Manager 212-980-9155 megha.tevar@tonixpharma.com

Locations
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United States, Alabama
Accel Research-Birmingham Clinical Research Unit Recruiting
Birmingham, Alabama, United States, 35216
Contact: Halie Youn    205-757-8208 ext 626    hyoun@accelclinical.com   
Contact: Connie    (205) 757-8212    cmoya@accelclinical.com   
Principal Investigator: Hayes M Williams, MD         
United States, California
Tonix Clinical Site Recruiting
Oceanside, California, United States, 92056
Contact: Al-malik Edwards       aedwards@excellresearch.com   
Principal Investigator: Sherry Soefje         
Tonix Clinical Site Recruiting
Santa Ana, California, United States, 92705
Contact: Olivia Molina    714-542-3008 ext 305    Omolina@syrentis.com   
Principal Investigator: John Gregory Duffy         
United States, Colorado
Tonix Clinical Site Not yet recruiting
Centennial, Colorado, United States, 80112
Contact: Maureen Collins    303-771-9000 ext 1248    mcollins@immunoe.com   
Principal Investigator: Isaac Melamed         
United States, Florida
Tonix Clinical Site Not yet recruiting
Aventura, Florida, United States, 33180
Contact: Norman Gaylis    305-932-4295    info@rheum-care.com   
Principal Investigator: Norman Gaylis         
Tonix Clinical Site Recruiting
Fort Myers, Florida, United States, 33912
Contact: Desiree Hinson    239-561-0009    desiree@gulfcoastclinicalresearch.com   
Contact: Meghan Corbett    239-561-0009    Meghan@gulfcoastclinicalresearch.com   
Principal Investigator: Zaheer Aslam         
Tonix Clinical Site Recruiting
Orlando, Florida, United States, 32801
Contact: William Lewis    407-425-5100      
Principal Investigator: Robert Molpus         
Tonix Clinical Site Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Michelle Reader    727-521-9137 ext 0703    michelle.reader@imaresearch.com   
Principal Investigator: Howard Chipman         
United States, Georgia
Tonix Clinical Site Not yet recruiting
Alpharetta, Georgia, United States, 30022
Tonix Clinical Site Recruiting
Atlanta, Georgia, United States, 30329
United States, Illinois
Tonix Clinical Site Not yet recruiting
Chicago, Illinois, United States, 60625
United States, Iowa
Tonix Clinical Site Recruiting
Des Moines, Iowa, United States, 50265
Contact: Shelby Simpson    515-223-2300    ssimpson@ictsiowa.com   
Contact: Rachel Thomas         
Principal Investigator: Kathleen Gannon         
Tonix Clinical Site Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Tonix Clinical Site Not yet recruiting
Prairie Village, Kansas, United States, 66208
Contact: Kristi Lakey    913-381-7180    klakey@cmr-kc.com   
Contact: Rebecca Thomas         
Principal Investigator: Haydn Mikel Thomas         
United States, Louisiana
Tonix Clinical Site Recruiting
New Orleans, Louisiana, United States, 70124
Contact: Patrick Dennis    504-336-2667      
Principal Investigator: Patrick Dennis         
Tonix Clinical Site Recruiting
Prairieville, Louisiana, United States, 70769
Contact: Taylor Sanders    225-412-0316      
Principal Investigator: Taylor Sanders         
United States, Massachusetts
Tonix Clinical Site Not yet recruiting
Boston, Massachusetts, United States, 02115
Tonix Clinical Site Recruiting
Boston, Massachusetts, United States, 02131
Contact: Joanne Monaghan    617-477-4868    Joanne.Monaghan@bostontrials.com   
Principal Investigator: Irina Mezhebovsky         
Tonix Clinical Site Recruiting
Methuen, Massachusetts, United States, 01844
Contact: Ashley Kennedy    978-655-7155    ashley.kennedy@activmedresearch.com   
Principal Investigator: Michael McCartney         
United States, Mississippi
Tonix Clinical Site Recruiting
Gulfport, Mississippi, United States, 39503
Contact: DelRicht    504-336-2667    info@delricht.com   
Principal Investigator: Sean Kerby         
United States, New Mexico
Tonix Clinical Site Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Shawn Johansson    505-848-3773      
Principal Investigator: Paul Lane         
United States, New York
Tonix Clinical Site Recruiting
New York, New York, United States, 10036
Contact: Ameenah Gaston    646-722-6214    Ameenah.Gaston@imaresearch.com   
Principal Investigator: James Greenwald         
Tonix Clinical Site Recruiting
Williamsville, New York, United States, 14221
Contact: Kaylie Briner    716-626-6320    upstatekaylie@gmail.com   
Principal Investigator: James Wild         
United States, North Carolina
Tonix Clinical Site Recruiting
Shelby, North Carolina, United States, 28150
Contact: Stephanie Hamrick    704-487-5228 ext 31    stephaniehamrickcrc@gmail.com   
Contact: Lisa s Mauney    704-487-5228 ext 14      
Principal Investigator: Stephen W Jones         
United States, Ohio
Tonix Clinical Site Recruiting
Columbus, Ohio, United States, 43215
Contact: Jennifer Botte    614-487-2560    info@remdavis.com   
Principal Investigator: Edward Cordasco         
Tonix Clinical Site Not yet recruiting
Dayton, Ohio, United States, 45432
Contact: Priyesh Mehta       pmehta@metamedresearch.com   
Principal Investigator: Priyesh Mehta         
United States, Oklahoma
Tonix Clinical Site Recruiting
Tulsa, Oklahoma, United States, 74133
United States, Texas
Tonix Clinical Site Not yet recruiting
Austin, Texas, United States, 78737
Contact: Kara Feary    512-521-0595      
Principal Investigator: Donal Garcia         
Tonix Clinical Site Recruiting
McKinney, Texas, United States, 75070
Contact: Jennifer Zomnir    972-807-5787      
Principal Investigator: Jennifer Zomnir         
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Herb Harris, MD, PhD Tonix Pharmaceuticals
More Information
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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: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonix Pharmaceuticals, Inc.:
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
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases