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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Tolerability of Single and Multiple Doses of Neumifil

NCT05093530

Viral Respiratory Tract Infection

COMPLETED PHASE1

Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

NCT03455491

Acute Respiratory Viral Infections Influenza

COMPLETED PHASE2

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19

NCT04363372

COVID-19

WITHDRAWN PHASE2

Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

NCT04343651

Coronavirus Disease 2019

COMPLETED PHASE2

SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation

NCT04631705

SARS-CoV-2 Infection

TERMINATED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase 2a randomized, masked, placebo-controlled clinical trial to evaluate the safety and efficacy of Xiflam for use in patients with signs/symptoms of Long COVID. Patients will be randomized to Xiflam the study drug (n=10) or Placebo (n=5). Both Xiflam and Placebo will be taken once daily by mouth for 12 weeks.

I. Baseline Screening Visit After obtaining informed consent and before treatment is initiated, an initial study visit will be conducted in person to confirm subject eligibility. Subjects will be asked complete a baseline questionnaire to assess signs and symptom severity. During this screening visit, a baseline blood sample will be obtained to determine any changes over time in any of the measured parameters. These include biomarkers of inflammation. Additional study procedures occurring during the baseline/screening phase of this study are outlined in the protocol. Patients who are found not to meet inclusion criteria, will not be entered into the treatment Phase of the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long COVID

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Phase 2 randomized, masked, placebo-controlled clinical trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

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

Group Type EXPERIMENTAL

Tonabersat

Intervention Type DRUG

Tonabersat 40mg. Two tablets per day

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 40mg, Two tablets per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tonabersat

Tonabersat 40mg. Two tablets per day

Intervention Type DRUG

Placebo

Placebo 40mg, Two tablets per day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Xiflam

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Have tested positive for COVID-19 irrespective of variant or timeframe.
2. Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).
3. Have recovered from the infection (tested negative for COVID-19).
4. 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.
5. Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection.
6. Female subjects must be:

1. Women of non-child-bearing potential, or
2. 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.
7. 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.
8. Willing and able to give informed consent and to comply with the study procedures and assessments.

Exclusion Criteria

1. No proof of having tested positive for COVID-19 infection at any time.
2. 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.
3. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
4. History of laser therapy in the macular region.
5. 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.
6. Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment.
7. 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.
8. Known hypersensitivity to Xiflam™ or excipients.
9. 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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No