Long COVID
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGTonabersat
Tonabersat 40mg. Two tablets per day
DRUGPlacebo
Placebo 40mg, Two tablets per day
Sponsors
Inflammx Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Phase 2 randomized, masked, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | 12 weeks | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter Chang, MD
Massachusetts Eye Research and Surgery Institution (MERSI)
Outcome results
None listed