Evaluating Xiflam for Long COVID Symptoms

A Phase 2 Study to Compare the Efficacy and Safety of Orally Administered Xiflam™ Therapy With Orally Administered Placebo in Patients With Ocular and Systemic Manifestations of Post COVID Sequelae Known as "Long" COVID

This study is testing if a new medication called Xiflam can help people with Long COVID feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Inflammx Therapeutics Inc (Industry-sponsored)
• Locations: 1 site (Waltham, Massachusetts)
• Trial ID: NCT06437223 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial aims to assess the safety and efficacy of Xiflam compared to a placebo in patients experiencing Long COVID symptoms. Participants will be randomly assigned to receive either Xiflam or a placebo orally once daily for 12 weeks. The study includes a baseline screening visit to confirm eligibility and assess symptom severity through questionnaires and blood samples. The trial seeks to determine if Xiflam can alleviate the persistent symptoms that some individuals experience after recovering from COVID-19.

Who should consider this trial

Good fit: Ideal candidates are individuals who have tested positive for COVID-19, have recovered, and continue to experience symptoms for 12 weeks or more.

Not a fit: Patients who have not tested positive for COVID-19 or do not exhibit persistent symptoms following recovery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Long COVID.

How similar studies have performed: While there have been various studies on Long COVID, the specific approach of using Xiflam is novel and has not been extensively tested in this context.

Eligibility criteria

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:

A subject will not be eligible for inclusion in this study if any of the following exclusion criteria apply:

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.

Where this trial is running

Waltham, Massachusetts

• Massachusetts Eye Research and Surgery Institution (MERSI) — Waltham, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Peter Chang, MD — Massachusetts Eye Research and Surgery Institution (MERSI)
• Study coordinator: Yasmin Massoudi

Conditions Long COVID