Can a plant compound tame COVID-19's deadly inflammation?
NCT ID NCT04476953
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tests whether fisetin, a natural compound found in fruits and vegetables, can reduce dangerous inflammation and improve oxygen levels in hospitalized COVID-19 patients. About 80 adults aged 60+ (or younger with certain health conditions) will receive either fisetin or a placebo for two days. The goal is to see if fisetin can prevent the disease from getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fisetin
- What this could lead to
- If it works, this could point toward a treatment that reduces severe inflammation and improves breathing in hospitalized COVID-19 patients.
- What could go wrong
- This is a small, early-phase pilot study with only 80 participants, so results may not be conclusive. The drug may not show benefit or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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80 people
The number who actually took part.
- Started
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Aug 2020
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria - Patients must meet all of the following inclusion criteria to be enrolled in this study. 1. Men or women 60 years of age or older OR Age 18 - 59 years WITH at least one of the following comorbidities: * BMI greater than or equal to 35 * Diabetes * Asthma/ Chronic Obstructive Pulmonary Disease (COPD) * Previous Myocardial Infarction * Previous Stroke/ Cerebrovascular Accident (CVA) * Hypertension/ Atherosclerosis/ Peripheral Vascular Disease * Smoking and/or vaping * Other conditions associated with senescent cell accumulation (i.e. previous chemotherapy or radiation) 2. SpO2 greater than or equal to 85% (on room air or less than or equal to 2 L of supplemental oxygen) 3. Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent 4. SARS-CoV-2 infection confirmed by PCR test at Mayo Clinic (or other CLIA certified) laboratory within 10 days prior to randomization. Exclusion Criteria - Patients who meet any of the following exclusion criteria are not to be enrolled in this study. General Exclusion Criteria 1. Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial 2. Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization 3. 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 4. Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration Laboratory Exclusion Criteria 5. Total bilirubin \>3X upper limit of normal or as per clinical judgment. 6. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) \>4x the upper limits of normal or as per clinical judgment. 7. Hemoglobin \<7 g/dL; white blood cell count ≤ 2,000/mm3 (\< or = 2.0 x 109/L) or \> or = 20,000/mm3 (\> or = 20 x 109/L); platelet count \< or = 40,000/µL (\< or = 40 x 109/L); absolute neutrophil count \< or = 1 x 109/L; lymphocyte count \<0.3 x 109/L at screening or as per clinical judgment. 8. Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder. 9. eGFR \<25 ml/ min/ 1.73 m2 or as per clinical judgment. 10. Plasma and/or serum glucose \>300 or as per clinical judgment. Clinical History Exclusion Criteria 11. Human immunodeficiency virus infection. 12. Known active hepatitis B or C infection. 13. Invasive fungal infection. 14. Uncontrolled (as per clinical judgement) pleural/pericardial effusions or ascites. 15. New/active invasive cancer except non-melanoma skin cancers. Medication Exclusion Criteria (See Appendices 1-3 for additional information) 16. Known hypersensitivity or allergy to Fisetin. 17. Patients currently using medications which utilize CYP450 2C9 for metabolism. These medications include: Fosphenytoin, Phenytoin, Warfarin, Glimepiride, Diclofenac, Bosentan, and Glyburide. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible. 18. Patients currently using medications which utilize CYP2C9, CYP2C19, CYP1A2, OATP1B1. These medications include: Olanzapine, Clozapine, Theophylline, Tizanidine, Warfarin, Rameltoen, Tacrine, Duloxetine, Mexiletine, Riluzole, and Atomoxetine. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible. 19. Patients currently using medications which are strong inhibitors of CYP3A4. These medications include: Atazanavir, Ceritinib, Clarithromycin, Darunavir, Idelalisib, Indinavir, Itraconazole, Ketoconazole, Lopinavir, Mefipristone, Nefazodone, Nelfinavir, Ombitasivir-paritaprevir-ritonivir, Ombitasivir-paritaprevir-ritonivir-plus dasabuvir, Posaconazole, Saquinavir, Telithromycin, Tucatinib, and Voriconazole. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible. 20. Patients currently using antifungals. If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are subtherapeutic or therapeutic. 21. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible: * Cardiac: digoxin, flecainide, amiodarone * Psychiatric: lithium, thioridazine * Neurologic: carbamazepine, phenobarbital * Antimicrobial/fungal: aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, paromomysin, streptomycin, tobramycin), rifampin * Anticoagulants/ Antiplatelets: warfarin * Others: methotrexate, nitroglycerin, St. John's wort, tyrosine kinase inhibitors, tacrine, diclofenac 22. Participation in other clinical trials involving treatment for SARS-CoV-2. (unless reviewed and approved by the Principal Investigator). Note that institutional standard of care treatment of SARS-CoV-2 including glucocorticoids, hydroxychloroquine, azithromycin, remdesivir, anti-spike antibodies, and/or convalescent plasma are not excluded from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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