Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06437223
Other study ID # IFX-LC001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 12, 2024
Est. completion date June 2025

Study information

Verified date May 2024
Source Inflammx Therapeutics Inc
Contact Yasmin Massoudi
Phone (781) 647-1431
Email ymassoudi@mersi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tonabersat
Tonabersat 40mg. Two tablets per day
Placebo
Placebo 40mg, Two tablets per day

Locations

Country Name City State
United States Massachusetts Eye Research and Surgery Institution (MERSI) Waltham Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Inflammx Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Endpoint Incidence and severity of ocular and systemic treatment emergent adverse events (TEAE) 12 weeks
Primary 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)
General health
Neurological signs/symptoms
Ocular signs/symptoms
Respiratory signs/symptoms
Gastrointestinal signs/symptoms
Cardiovascular signs/symptoms
Musculoskeletal signs/symptoms
Dermatological signs/symptoms
Mental Health signs/symptoms
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 Secondary Endpoint Complete Blood Count (CBC) including biomarkers of inflammation Physical Examination including electrocardiogram (EKG)
Change in laboratory values including inflammatory markers, e.g., C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), Antinuclear Antibody (ANA)
12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05926505 - Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome Phase 2/Phase 3
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Completed NCT05552612 - Health-related Quality of Life and Long COVID
Completed NCT05531019 - COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A N/A
Not yet recruiting NCT04949386 - Safety, Tolerability and Efficacy of S-1226 in Post-COVID-19 Subjects With Persistent Respiratory Symptoms. Phase 2
Recruiting NCT06118112 - Living With Long COVID: LONGCOVID-EXPERIENCE
Completed NCT05185674 - Sociodemographic, Clinical, Quality of Life and Health Care Conditions in COVID-19 Survivors.
Active, not recruiting NCT05965739 - RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms N/A
Active, not recruiting NCT05965752 - RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms N/A
Completed NCT05812209 - Stellate Ganglion Block to Treat Long COVID 19 Case Series
Recruiting NCT05606211 - Pain in Long COVID-19: The Role of Sleep
Active, not recruiting NCT05713266 - Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)
Completed NCT05601180 - Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID. N/A
Completed NCT05679505 - Vagus Nerve Stimulation for Post-COVID Syndrome N/A
Not yet recruiting NCT06045338 - Mind Body Intervention for Long COVID N/A
Recruiting NCT06091358 - Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation. N/A
Recruiting NCT05566392 - Longterm Influence of Pediatric Long COVID Syndrome
Recruiting NCT05855369 - Smell Training and Trigeminal Nerve Stimulation for COVID-related Smell Loss Phase 2/Phase 3
Recruiting NCT05572346 - Digital App for Telerehabilitation in Respiratory Diseases
Recruiting NCT06316843 - Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 Phase 2