Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT05593588
The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 2
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29
Looks exactly like the study drug, but it contains no active ingredient. Administered orally on days 0, 1, 28 and 29
Time frame: Baseline, 6 months
Measured by percentage of activated CD4+25+ T cells
Time frame: Baseline, 6 months
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)
Time frame: Baseline, 3 months, 6 months
Number of subjects to have a 10% improvement with the CT scoring system. Radiologist will score the CT scans at each time point and changes in score at each time point will be noted.
Time frame: 6 months
Number of MRI images that were used to assess for GLILD compared to High-resolution Computed Tomography (HRCT) use
Time frame: 6 months
Number of subjects to experience infectious complications
Time frame: 6 months
Number of adverse events reported
Time frame: Baseline, 6 months
Measured using the RAND 36-Short Form Survey Instrument (SF-36). The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability
Time frame: Baseline, 6 months
Number of subjects to have a 10% improvement in 6 minute walk test. The 6 minute walk test measures the distance a person is able to walk in 6 minutes.
Avni Joshi
Other
Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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