Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC)

NCT06437223 | Completed Phase 2 FDA Drug

• 1 other identifier: IFX-LC001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID. Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Primary outcomes are change from baseline for signs and symptoms measured by a Visual Analogue Scale (VAS) instrument. Reporting done by the patient on a 0-100 scale. Scale measures severity from none (0) to severe (100) for multiple signs and symptoms, for the different systems involved in this disease state (see below) 1. General health 2. Neurological signs/symptoms 3. Ocular signs/symptoms 4. Respiratory signs/symptoms 5. Gastrointestinal signs/symptoms 6. Cardiovascular signs/symptoms 7. Musculoskeletal signs/symptoms 8. Dermatological signs/symptoms 9. Mental Health signs/symptoms 10. Miscellaneous signs/symptoms which may not be captured above. Since Long COVID is a multi-system disease, patients will only score on the severity scale of the signs/symptoms which are of clinical significance to that particular patient.

  12 weeks

Secondary Outcomes (1)

• Secondary Endpoint

  12 weeks

Other Outcomes (1)

• Safety Endpoint

  12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

IFX-LC001 Tonabersat tablets 40mg tablets or placebo Take two tablets once per day

Drug: Tonabersat

Placebo

PLACEBO COMPARATOR

IFX-LC001Tonabersat tablets 40mg tablets or placebo Take two tablets once per day

Drug: Placebo

Interventions

Tonabersat DRUG

Tonabersat 40mg. Two tablets per day

Also known as: Xiflam

Experimental

Placebo DRUG

Placebo 40mg, Two tablets per day

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have tested positive for COVID-19 irrespective of variant or timeframe.
• Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).
• Have recovered from the infection (tested negative for COVID-19).
• Following negative COVID-19 testing, continued to demonstrate signs/symptoms which were not pre-existing. The signs/symptoms must have persisted for 12 weeks or more.
• Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection.
• Female subjects must be:
• Women of non-child-bearing potential, or
• Women of child-bearing potential with a negative pregnancy test at screening, must agree to use approved methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
• Males with female partners of child-bearing potential must agree to use approved methods of contraception and agree to refrain from donating sperm for the duration of the study.
• Willing and able to give informed consent and to comply with the study procedures and assessments.

You may not qualify if:

• No proof of having tested positive for COVID-19 infection at any time.
• Presence of an active ocular/systemic disease that in the opinion of the Investigator existed prior to COVID-19 infection and is not likely a LC related condition.
• Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
• History of laser therapy in the macular region.
• Any ocular or systemic condition that in the opinion of the Investigator is not LC related (e.g., pre-existing cataract) that may require surgery or medical intervention during the study period.
• Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment.
• Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
• Known hypersensitivity to Xiflam™ or excipients.
• Known history of alcohol and/or drug abuse within 12 months prior to Visit 1 Screening that, in the opinion of the Investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.

Sponsors & Collaborators

• Inflammx Therapeutics Inc: lead

Study Sites (1)

Massachusetts Eye Research and Surgery Institution (MERSI)

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

tonabersat

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Chang, MD

  Massachusetts Eye Research and Surgery Institution (MERSI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phase 2 randomized, masked, placebo-controlled clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 31, 2024
• Study Start: March 12, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)