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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

CompletedPhase 2NCT05472090
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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)
Conditions
  • Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
  • Covid-19
  • Long COVID
  • Long Haul COVID
Interventions
  • Drug: TNX-102 SL
  • Drug: Placebo SL Tablet
Sponsor
Tonix Pharmaceuticals, Inc.
Start date
2022-08-18
Primary completion
2023-07-12
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
29

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05472090