Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC)

Prior treatment

• 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.
• Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
• Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment.
• 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.

Other illness

• No proof of having tested positive for COVID-19 infection at any time.
• History of laser therapy in the macular region.
• 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.
• Known hypersensitivity to Xiflam™ or excipients.

Lab values

• 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.

Other

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

• 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.