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Post-Acute Sequelae of SARS-CoV-2 (PASC) InfectionPhase 2PREVAILNCT05472090

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

A Phase 2 study testing TNX-102 SL in people with Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection and COVID-19, run by Tonix Pharmaceuticals, Inc. at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
TNX-102 SL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
29 sitesUnited States
Study dates
18 Aug 2022to 27 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Tonix Clinical Site

    Albuquerque, New Mexico, 87109

  • Tonix Clinical Site

    Alpharetta, Georgia, 30022

  • Tonix Clinical Site

    Atlanta, Georgia, 30329

  • Tonix Clinical Site

    Austin, Texas, 78737

  • Tonix Clinical Site

    Aventura, Florida, 33180

  • Accel Research-Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216

  • Tonix Clinical Site

    Boston, Massachusetts, 02115

  • Tonix Clinical Site

    Boston, Massachusetts, 02131

  • Tonix Clinical Site

    Centennial, Colorado, 80112

  • Tonix Clinical Site

    Chicago, Illinois, 60625

  • Tonix Clinical Site

    Columbus, Ohio, 43215

  • Tonix Clinical Site

    Dayton, Ohio, 45432

  • Tonix Clinical Site

    Des Moines, Iowa, 50265

  • Tonix Clinical Site

    Fort Myers, Florida, 33912

  • Tonix Clinical Site

    Gulfport, Mississippi, 39503

  • Tonix Clinical Site

    Iowa City, Iowa, 52242

  • Tonix Clinical Site

    McKinney, Texas, 75070

  • Tonix Clinical Site

    Methuen, Massachusetts, 01844

  • Tonix Clinical Site

    New Orleans, Louisiana, 70124

  • Tonix Clinical Site

    New York, New York, 10036

  • Tonix Clinical Site

    Oceanside, California, 92056

  • Tonix Clinical Site

    Orlando, Florida, 32801

  • Tonix Clinical Site

    Prairie Village, Kansas, 66208

  • Tonix Clinical Site

    Prairieville, Louisiana, 70769

  • Tonix Clinical Site

    Santa Ana, California, 92705

  • Tonix Clinical Site

    Shelby, North Carolina, 28150

  • Tonix Clinical Site

    St. Petersburg, Florida, 33709

  • Tonix Clinical Site

    Tulsa, Oklahoma, 74133

  • Tonix Clinical Site

    Williamsville, New York, 14221

Other trials in United States

About this study

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)

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.

Being tested
TNX-102 SL, Placebo SL Tablet
Keywords
Multi-site pain, Sleep disturbance, PASC, COVID-19, Long COVID, Coronavirus infections
Medical subject headings
Infections, COVID-19, Post-Acute COVID-19 Syndrome, Parasomnias, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNX-102 SLDrug

    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 SL TabletDrug

    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.

Study groups in NCT05472090
Study groupRoleWhat they receive
TNX-102 SL Tablet, 5.6 mgExperimental1 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.
Receives: Drug: TNX-102 SL
Placebo SL TabletPlacebo comparator1 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.
Receives: Drug: Placebo SL Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 14

Secondary outcomes (3)

  1. 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.

    Measured: Week 14

  2. 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.

    Measured: Week 14

  3. 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.

    Measured: Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start18 Aug 2022
  3. Primary completion12 Jul 2023
  4. Study completion27 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05472090
Sponsor's protocol ID
TNX-CY-PA201
Acronym
PREVAIL
Status last verified
Nov 2024
First submitted
21 Jul 2022
Last updated
26 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TNX-102 SL in people with Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection and COVID-19, run by Tonix Pharmaceuticals, Inc. at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Diary Pain NRS (time frame: Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05472090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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