Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Lo… (NCT06437223) | Clinical Trial Compass
CompletedPhase 2
Study of Xiflamâ„¢ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC)
United States16 participantsStarted 2024-03-12
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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.
Exclusion criteria
✕. No proof of having tested positive for COVID-19 infection at any time.
✕. 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.
✕. 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.
✕. Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment.
✕. 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.
✕. Known hypersensitivity to Xiflam™ or excipients.