Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
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:
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups, including a placebo group
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Central trial contact
Yasmin Massoudi; Tate Valerio
Data sourced from clinicaltrials.gov
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