TNX-102 SL for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tonix Clinical Site, Atlanta, GA
COVID19 (disease)+7 More
TNX-102 SL - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • COVID19 (disease)
  • COVID-19
  • Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
  • Long COVID
  • Long Haul COVID

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID19 (disease)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Week 14

Week 14
Mean Pain Score
Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for COVID19 (disease)

Side Effects for

TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
13%Sinusitis
10%Fatigue
8%Upper respiratory tract infection
5%Somnolence
5%Paraesthesia
5%Constipation
3%Glossodynia
1%Brain stem glioma
1%Hypoaesthesia oral
1%Ankle fracture
1%Abdominal hernia
1%Intraductal proliferative breast lesion
1%Anxiety
0%Pubic fracture
0%Malignant melanoma
0%Product taste abnormal
0%Vertigo
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT02015234) in the TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg ARM group. Side effects include: Sinusitis with 13%, Fatigue with 10%, Upper respiratory tract infection with 8%, Somnolence with 5%, Paraesthesia with 5%.

Trial Design

2 Treatment Groups

TNX-102 SL Tablet, 5.6 mg
1 of 2
Placebo SL Tablet
1 of 2
Experimental Treatment
Non-Treatment Group

470 Total Participants · 2 Treatment Groups

Primary Treatment: TNX-102 SL · Has Placebo Group · Phase 2

TNX-102 SL Tablet, 5.6 mg
Drug
Experimental Group · 1 Intervention: TNX-102 SL · Intervention Types: Drug
Placebo SL Tablet
Drug
PlaceboComparator Group · 1 Intervention: Placebo SL Tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TNX-102 SL
2019
Completed Phase 3
~1090

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 14
Closest Location: Tonix Clinical Site · Atlanta, GA
Photo of Atlanta 1Photo of Atlanta 2Photo of Atlanta 3
2020First Recorded Clinical Trial
0 TrialsResearching COVID19 (disease)
2 CompletedClinical Trials

Who is running the clinical trial?

Tonix Pharmaceuticals, Inc.Lead Sponsor
26 Previous Clinical Trials
4,756 Total Patients Enrolled
Herb Harris, MD, PhDStudy DirectorTonix Pharmaceuticals
1 Previous Clinical Trials
685 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, 18 to 65 years of age, inclusive.
You have 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.
You have symptoms of COVID-19 infection that have been present for at least 3 months but no longer than 18 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.