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

Trial Summary

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.

How does the drug Xiflam differ from other treatments for post-COVID syndrome?

Xiflam is unique because it may target the persistent inflammation seen in post-COVID syndrome, which is linked to high levels of certain cytokines (proteins that affect the immune system) like IL-1β, TNF-α, and MIP-1α. This approach could help manage the ongoing inflammatory response that other treatments might not specifically address. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Peter Chang, MD

Principal Investigator

Massachusetts Eye Research and Surgery Institution (MERSI)

Eligibility Criteria

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.

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

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Circulating Cytokines and Lymphocyte Subsets in Patients Who Have Recovered from COVID-19. [2020]

2. Switzerland 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Distal Lung Inflammation Assessed by Alveolar Concentration of Nitric Oxide Is an Individualised Biomarker of Severe COVID-19 Pneumonia. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

First Reported Use of Highly Adsorptive Hemofilter in Critically Ill COVID-19 Patients in the USA. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[18F]FDG PET/CT in Patients Affected by SARS-CoV-2 and Lymphoproliferative Disorders and Treated with Tocilizumab. [2023]