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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
COVID-19
Long COVID
Long Haul COVID
Keywords: Multi-site pain
Sleep disturbance
PASC
COVID-19
Long COVID
Coronavirus infections
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Daily Diary Pain NRS
timeFrame: Week 14
Secondary outcomes:
measure: Daily Diary Sleep Quality NRS
timeFrame: Week 14
measure: PROMIS Fatigue -Short Form 8a
timeFrame: Week 14
measure: PROMIS Cognitive Function - Abilities-Short Form 8a
timeFrame: Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research-Birmingham Clinical Research Unit
state: Alabama
city: Oceanside
country: United States
facility: Tonix Clinical Site
state: California
city: Santa Ana
country: United States
facility: Tonix Clinical Site
state: California
city: Centennial
country: United States
facility: Tonix Clinical Site
state: Colorado
city: Aventura
country: United States
facility: Tonix Clinical Site
state: Florida
city: Fort Myers
country: United States
facility: Tonix Clinical Site
state: Florida
city: Orlando
country: United States
facility: Tonix Clinical Site
state: Florida
city: Saint Petersburg
country: United States
facility: Tonix Clinical Site
state: Florida
city: Alpharetta
country: United States
facility: Tonix Clinical Site
state: Georgia
city: Atlanta
country: United States
facility: Tonix Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Tonix Clinical Site
state: Illinois
city: Des Moines
country: United States
facility: Tonix Clinical Site
state: Iowa
city: Iowa City
country: United States
facility: Tonix Clinical Site
state: Iowa
city: Prairie Village
country: United States
facility: Tonix Clinical Site
state: Kansas
city: New Orleans
country: United States
facility: Tonix Clinical Site
state: Louisiana
city: Prairieville
country: United States
facility: Tonix Clinical Site
state: Louisiana
city: Boston
country: United States
facility: Tonix Clinical Site
state: Massachusetts
city: Boston
country: United States
facility: Tonix Clinical Site
state: Massachusetts
city: Methuen
country: United States
facility: Tonix Clinical Site
state: Massachusetts
city: Gulfport
country: United States
facility: Tonix Clinical Site
state: Mississippi
city: Albuquerque
country: United States
facility: Tonix Clinical Site
state: New Mexico
city: New York
country: United States
facility: Tonix Clinical Site
state: New York
city: Williamsville
country: United States
facility: Tonix Clinical Site
state: New York
city: Shelby
country: United States
facility: Tonix Clinical Site
state: North Carolina
city: Columbus
country: United States
facility: Tonix Clinical Site
state: Ohio
city: Dayton
country: United States
facility: Tonix Clinical Site
state: Ohio
city: Tulsa
country: United States
facility: Tonix Clinical Site
state: Oklahoma
city: Austin
country: United States
facility: Tonix Clinical Site
state: Texas
city: McKinney
country: United States
facility: Tonix Clinical Site
state: Texas
Study officials:
affiliation: Tonix Pharmaceuticals
name: Herb Harris, MD, PhD
role: STUDY_DIRECTOR
References: