Xiflam for Post-COVID Syndrome

Overseen By Megan Mitchell

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inflammx Therapeutics Inc

Disqualifiers: Active disease, Intraocular surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Xiflam to determine its effectiveness for Long COVID, a condition where symptoms from a past COVID-19 infection persist for weeks or months. Participants will take either Xiflam or a placebo (a pill with no active ingredients) once a day for 12 weeks to assess Xiflam's safety and effectiveness. The study seeks individuals who had COVID-19, have recovered, and still experience symptoms like extreme fatigue or new eye problems. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that Xiflam is likely to be safe for humans?

Research has shown that Xiflam, also known as tonabersat, is being tested for safety in people with Long COVID. This trial is in an early stage, indicating that initial tests have demonstrated some safety, but more information is needed.

Although detailed safety data for Xiflam is not yet available, reaching this stage suggests it is likely safe enough for human testing. Researchers will closely monitor participants for any side effects, ensuring that any unwanted effects are quickly identified and managed.

For those considering joining the trial, it is important to know that close monitoring is a key part of the study, which helps protect participants' health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Post-COVID Syndrome, which often focus on managing symptoms with pain relievers and steroids, Xiflam introduces a unique approach. Xiflam features Tonabersat, a new active ingredient that targets neuronal gap junctions, potentially addressing the neurological aspects of the syndrome directly. Researchers are excited because this mechanism could offer more targeted relief and improve quality of life for those suffering from lingering post-COVID symptoms.

What evidence suggests that Xiflam might be an effective treatment for Long COVID?

Research has shown that Xiflam, which participants in this trial may receive, might help treat Long COVID symptoms. Early results suggest that people taking Xiflam feel better than those taking a placebo. Xiflam reduces inflammation, which is believed to contribute to Long COVID. Studies on similar treatments have shown they can help with symptoms like tiredness and brain fog. While more research is needed, these early findings offer hope for those dealing with Long COVID. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter Chang, MD

Principal Investigator

Massachusetts Eye Research and Surgery Institution (MERSI)

Are You a Good Fit for This Trial?

This trial is for individuals who have recovered from COVID-19 but are experiencing lingering effects known as Long COVID. The specifics of inclusion and exclusion criteria were not provided, so participants should inquire about detailed eligibility requirements.

Inclusion Criteria

I agree to use contraception and not donate sperm during the study.

Willing and able to give informed consent and to comply with the study procedures and assessments

I have ongoing health issues like eye inflammation or extreme tiredness since having COVID-19.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive Xiflam or placebo orally once a day for 12 weeks

12 weeks

Weekly visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Xiflam

Trial Overview The study aims to test the safety and effectiveness of a treatment called Xiflam compared to a placebo in patients with Long COVID. Participants will be randomly assigned to receive either Xiflam or placebo once daily for 12 weeks.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Inflammx Therapeutics Inc

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

A study involving 68 participants (14 healthy donors and 54 with confirmed SARS-CoV-2 infection) found that specific cytokines (IL-1β, MIP-1α, and TNF-α) were significantly elevated in patients who developed post COVID-19 symptoms one month after infection, suggesting a link between persistent inflammation and long COVID.

The research indicates that monitoring these inflammatory markers could help predict which patients are at risk of developing long COVID, highlighting the importance of inflammation in the disease's long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Levels of IL-1β, TNF-α and MIP-1α One Month after the Onset of the Acute SARS-CoV-2 Infection, Predictors of Post COVID-19 in Hospitalized Patients. Alonso-Domínguez, J., Gallego-Rodríguez, M., Martínez-Barros, I., et al.[2023]

Two weeks after recovering from COVID-19, patients showed significantly lower levels of various immune cells, including total lymphocytes and T cell subsets, compared to healthy controls, indicating a compromised immune status post-infection.

Despite the lower immune cell counts, patients exhibited elevated levels of several cytokines, suggesting a prolonged hyperinflammatory response that may require ongoing medical monitoring after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating Cytokines and Lymphocyte Subsets in Patients Who Have Recovered from COVID-19. Hasichaolu, ., Zhang, X., Li, X., et al.[2020]

The oXiris® hemofilter, used in critically ill COVID-19 patients, effectively reduced inflammatory markers such as interleukin-6, ESR, and CRP, indicating a positive impact on the inflammatory response.

In a small study, the oXiris® filter improved clinical outcomes in two out of three patients, suggesting its potential as an effective adjuvant therapy for managing severe COVID-19 complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Reported Use of Highly Adsorptive Hemofilter in Critically Ill COVID-19 Patients in the USA. Padala, SA., Vakiti, A., White, JJ., et al.[2020]

In a study of 169 patients recovering from COVID-19, those with more severe initial infections showed a higher prevalence of abnormal pulmonary function tests (PFTs), indicating lasting lung issues post-infection.

While exhaled nitric oxide (FeNO) levels remained normal across all severity groups, patients with severe COVID-19 had significantly elevated levels of distal lung inflammation (CaNO), suggesting that this inflammation could contribute to long-term lung complications like pulmonary fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal Lung Inflammation Assessed by Alveolar Concentration of Nitric Oxide Is an Individualised Biomarker of Severe COVID-19 Pneumonia. Hua-Huy, T., Günther, S., Lorut, C., et al.[2022]

Tocilizumab, an anti-IL-6 receptor monoclonal antibody, effectively treated interstitial pneumonia in COVID-19 patients with lymphoproliferative disorders, as shown by improvements in [18F]FDG PET/CT imaging after 14 days.

The treatment led to symptom improvement and normalization of lung imaging in one patient, while the other patient showed persistent symptoms, highlighting the variability in response to therapy among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]FDG PET/CT in Patients Affected by SARS-CoV-2 and Lymphoproliferative Disorders and Treated with Tocilizumab. Signore, A., Lauri, C., Bianchi, MP., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06437223

Study of Xiflam™ Treatment in Patients Post COVID-19 ... 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 ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/493920

Study of Xiflam™ Treatment in Patients Post COVID-19 ... 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 ...

3. withpower.com withpower.com/trial/phase-2-long-covid-2-2024-96277

Xiflam for Post-COVID Syndrome Xiflam. Trial Overview The study aims to test the safety and effectiveness of a treatment called Xiflam compared to a placebo in patients with Long COVID.

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-xiflam-treatment-patients-post-covid-19-infection-suffering-what-trial-nct06437223

Study of Xiflam™ Treatment in Patients Post COVID-19 ... Participants in this study will receive close monitoring of their Long COVID symptoms and may experience relief or improvement in their symptoms if they receive ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0140673

Post-Acute COVID-19 Syndrome (DBCOND0140673) Associated Data ; NCT05013723. Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome, No drug interventions ; NCT06437223. Study of Xiflam™ ...

6. esmed.org esmed.org/long-covid-clinical-development-and-outcome-assessment/

Long-COVID Clinical Development and Outcome Assessment The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) patient-reported outcome measure for Long Covid or Post-COVID-19 syndrome. J Med Virol 2022 ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=0ef2c424-bdc9-42e7-b4f9-06a21110e5ee

Xiflam (tonabersat) / Sawai Pharma, InflammX Delicious. May 31, 2024. Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC) (clinicaltrials.gov) ...