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The purpose of this study is to test whether Fisetin, a senolytic drug can assist in the reduction of complications in patients with COVID-19 infection.
To determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19 and to determine the safety of treatment with Fisetin in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Subjects will receive treatment drug Fisetin |
|
| Placebo | Placebo Comparator | Subjects will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisetin | Drug | ~20mg/kg /day oral for four days (days 0,1 and days 8,9) |
|
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization (WHO) Ordinal Scale Score | The number of subjects who scored as No limitations (Score 0-1) and Ambulatory, limitations (score 2-8) on the WHO Ordinal Scale score. The 9 points of the WHO ordinal clinical severity scale are as follows: 0: no clinical or virological evidence of infection; 1: ambulatory, no activity limitation; 2: ambulatory, activity limitation; 3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen mask or nasal prongs; 5: hospitalized, noninvasive mechanical ventilation (NIMV) or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation (ECMO); 8: death. Total scores range from 0-8. Lower scales indicate less limitations, higher scores indicate more limitations. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | The number of serious adverse events reported | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avni Y. Joshi, MD, MS | Mayo Clinic | Principal Investigator |
| James L Kirkland, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Subjects who received treatment drug Fisetin Fisetin: ~20mg/kg /day oral for four days (days 0,1 and days 8,9) |
| FG001 | Placebo | Subjects who received placebo Placebo: Looks exactly like the study drug, but it contains no active ingredient. Oral for four days (days 0,1 and days 8,9) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Subjects who received treatment drug Fisetin Fisetin: ~20mg/kg /day oral for four days (days 0,1 and days 8,9) |
| BG001 | Placebo | Subjects who received placebo Placebo: Looks exactly like the study drug, but it contains no active ingredient. Oral for four days (days 0,1 and days 8,9) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | World Health Organization (WHO) Ordinal Scale Score | The number of subjects who scored as No limitations (Score 0-1) and Ambulatory, limitations (score 2-8) on the WHO Ordinal Scale score. The 9 points of the WHO ordinal clinical severity scale are as follows: 0: no clinical or virological evidence of infection; 1: ambulatory, no activity limitation; 2: ambulatory, activity limitation; 3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen mask or nasal prongs; 5: hospitalized, noninvasive mechanical ventilation (NIMV) or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation (ECMO); 8: death. Total scores range from 0-8. Lower scales indicate less limitations, higher scores indicate more limitations. | Two subjects in each arm did not return for the 60-day evaluation period. | Posted | Count of Participants | Participants | 60 days |
|
Adverse Events were collected from baseline to end of study, approximately 60 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Subjects who received treatment drug Fisetin Fisetin: ~20mg/kg /day oral for four days (days 0,1 and days 8,9) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Change in stool color | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James L. Kirkland, M.D., Ph.D. | Mayo Clinic | 507-538-3817 | Kirkland.James@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2022 | Jul 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C017875 | fisetin |
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| Placebo | Drug | Looks exactly like the study drug, but it contains no active ingredient . Oral for four days (days 0,1 and days 8,9) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment Group |
Subjects who received treatment drug Fisetin Fisetin: ~20mg/kg /day oral for four days (days 0,1 and days 8,9) |
| OG001 | Placebo | Subjects who received placebo Placebo: Looks exactly like the study drug, but it contains no active ingredient. Oral for four days (days 0,1 and days 8,9) |
|
|
| Secondary | Serious Adverse Events | The number of serious adverse events reported | Posted | Number | number of serious adverse events | 60 days |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 17 |
| 29 |
| EG001 | Placebo | Subjects who received placebo Placebo: Looks exactly like the study drug, but it contains no active ingredient. Oral for four days (days 0,1 and days 8,9) | 0 | 26 | 2 | 26 | 16 | 26 |
| Robotic assisted total arthroplasty (right) | Surgical and medical procedures | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Infectious Rash | Infections and infestations | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Worsening Headache | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Non cardia chest pain | Cardiac disorders | Systematic Assessment |
|
| Systolic murmur | Cardiac disorders | Systematic Assessment |
|
| tachycardia | Cardiac disorders | Systematic Assessment |
|
| ear pain, left | Ear and labyrinth disorders | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| watering eyes (epiphora) | Eye disorders | Systematic Assessment |
|
| Pancreatic cyst | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| edema, hand, bilateral | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| flu like symptoms | General disorders | Systematic Assessment |
|
| Allergy Unspecified | Immune system disorders | Systematic Assessment |
|
| Lyme's Disease | Immune system disorders | Systematic Assessment |
|
| Vitamin D Deficiency | Immune system disorders | Systematic Assessment |
|
| Otitis media | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| bacteriuria | Infections and infestations | Systematic Assessment |
|
| conjunctivitis | Infections and infestations | Systematic Assessment |
|
| fatigue | Infections and infestations | Systematic Assessment |
|
| pharyngitis | Infections and infestations | Systematic Assessment |
|
| urinary tract infections (UTI) | Infections and infestations | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| polyp colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Anosmia | Nervous system disorders | Systematic Assessment |
|
| acute frontal lobe stroke | Nervous system disorders | Systematic Assessment |
|
| ageusia | Nervous system disorders | Systematic Assessment |
|
| amnesia | Nervous system disorders | Systematic Assessment |
|
| migraine | Nervous system disorders | Systematic Assessment |
|
| worsening Parkinson's Disease | Nervous system disorders | Systematic Assessment |
|
| anxiety attack | Psychiatric disorders | Systematic Assessment |
|
| Colic Renal | Renal and urinary disorders | Systematic Assessment |
|
| Nephrolithiasis Calcium Oxalate | Renal and urinary disorders | Systematic Assessment |
|
| bacterial vaginosis | Reproductive system and breast disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| asthma with exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| change in smell | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| thrush | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| arthoplasty | Surgical and medical procedures | Systematic Assessment |
|
| right shoulder arthroscopy, rotator cuff, repair | Surgical and medical procedures | Systematic Assessment |
|
| hypertension | Vascular disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |