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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Tonabersat 40mg. Two tablets per day
Placebo 40mg, Two tablets per day
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, United States
RECRUITINGPrimary 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) 1. General health 2. Neurological signs/symptoms 3. Ocular signs/symptoms 4. Respiratory signs/symptoms 5. Gastrointestinal signs/symptoms 6. Cardiovascular signs/symptoms 7. Musculoskeletal signs/symptoms 8. Dermatological signs/symptoms 9. Mental Health signs/symptoms 10. 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.
Time frame: 12 weeks
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)
Time frame: 12 weeks
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