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

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

August 18, 2022

Primary Completion Date

July 12, 2023

Study Completion Date

July 27, 2023

Conditions
Post-Acute Sequelae of SARS-CoV-2 (PASC) InfectionCOVID-19Long COVIDLong Haul COVID
Interventions
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.

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.

Trial Locations (29)

10036

Tonix Clinical Site, New York

14221

Tonix Clinical Site, Williamsville

28150

Tonix Clinical Site, Shelby

30022

Tonix Clinical Site, Alpharetta

30329

Tonix Clinical Site, Atlanta

32801

Tonix Clinical Site, Orlando

33180

Tonix Clinical Site, Aventura

33709

Tonix Clinical Site, St. Petersburg

33912

Tonix Clinical Site, Fort Myers

35216

Accel Research-Birmingham Clinical Research Unit, Birmingham

39503

Tonix Clinical Site, Gulfport

43215

Tonix Clinical Site, Columbus

45432

Tonix Clinical Site, Dayton

50265

Tonix Clinical Site, Des Moines

52242

Tonix Clinical Site, Iowa City

60625

Tonix Clinical Site, Chicago

66208

Tonix Clinical Site, Prairie Village

70124

Tonix Clinical Site, New Orleans

70769

Tonix Clinical Site, Prairieville

74133

Tonix Clinical Site, Tulsa

75070

Tonix Clinical Site, McKinney

78737

Tonix Clinical Site, Austin

80112

Tonix Clinical Site, Centennial

87109

Tonix Clinical Site, Albuquerque

92056

Tonix Clinical Site, Oceanside

92705

Tonix Clinical Site, Santa Ana

02115

Tonix Clinical Site, Boston

02131

Tonix Clinical Site, Boston

01844

Tonix Clinical Site, Methuen

All Listed Sponsors
lead

Tonix Pharmaceuticals, Inc.

INDUSTRY