Overview
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.
Eligibility
Inclusion Criteria:
- Have tested positive for COVID-19 irrespective of variant or timeframe.
- Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).
- Have recovered from the infection (tested negative for COVID-19).
- 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.
- Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection.
- Female subjects must be:
- Women of non-child-bearing potential, or
- 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.
- 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.
- 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.