Trial Outcomes & Findings for COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications (NCT NCT04771611)

Last Updated: 2023-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

60 days

Results posted on

2023-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Subjects who received treatment drug Fisetin Fisetin: \~20mg/kg /day oral for four days (days 0,1 and days 8,9)	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)
Overall Study STARTED	29	26
Overall Study COMPLETED	29	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=29 Participants Subjects who received treatment drug Fisetin Fisetin: \~20mg/kg /day oral for four days (days 0,1 and days 8,9)	Placebo n=26 Participants 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)	Total n=55 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 15.4 • n=5 Participants	58.7 years STANDARD_DEVIATION 12.9 • n=7 Participants	58.1 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	26 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Population: Two subjects in each arm did not return for the 60-day evaluation period.

Outcome measures

Outcome measures
Measure	Treatment Group n=27 Participants Subjects who received treatment drug Fisetin Fisetin: \~20mg/kg /day oral for four days (days 0,1 and days 8,9)	Placebo n=24 Participants 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)
World Health Organization (WHO) Ordinal Scale Score No limitations (Score 0-1)	26 Participants	22 Participants
World Health Organization (WHO) Ordinal Scale Score Ambulatory, limitations (score 2-8)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 60 days

The number of serious adverse events reported

Outcome measures

Outcome measures
Measure	Treatment Group n=29 Participants Subjects who received treatment drug Fisetin Fisetin: \~20mg/kg /day oral for four days (days 0,1 and days 8,9)	Placebo n=26 Participants 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)
Serious Adverse Events	0 number of serious adverse events	2 number of serious adverse events

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=29 participants at risk Subjects who received treatment drug Fisetin Fisetin: \~20mg/kg /day oral for four days (days 0,1 and days 8,9)	Placebo n=26 participants at risk 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)
Infections and infestations Urinary Tract Infection	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Surgical and medical procedures Robotic assisted total arthroplasty (right)	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.

Other adverse events

Additional Information

James L. Kirkland, M.D., Ph.D.

Mayo Clinic

Phone: 507-538-3817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Group n=29 participants at risk Subjects who received treatment drug Fisetin Fisetin: \~20mg/kg /day oral for four days (days 0,1 and days 8,9)	Placebo n=26 participants at risk 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)
Gastrointestinal disorders Change in stool color	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	7.7% 2/26 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Cardiac disorders Chest pain	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders Diarrhea	6.9% 2/29 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations Sinusitis	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations Infectious Rash	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Musculoskeletal and connective tissue disorders Back Pain	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders Headache	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders Worsening Headache	6.9% 2/29 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders sore throat	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Skin and subcutaneous tissue disorders hyperhidrosis	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Skin and subcutaneous tissue disorders Rash	6.9% 2/29 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Cardiac disorders Palpitations	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Cardiac disorders Non cardia chest pain	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Cardiac disorders Systolic murmur	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Cardiac disorders tachycardia	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Ear and labyrinth disorders ear pain, left	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Ear and labyrinth disorders vertigo	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Eye disorders watering eyes (epiphora)	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders abdominal distension	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders abdominal pain	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders dyspepsia	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders flatulence	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Gastrointestinal disorders vomiting	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
General disorders edema, hand, bilateral	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
General disorders fatigue	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
General disorders flu like symptoms	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Immune system disorders Allergy Unspecified	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Immune system disorders Lyme's Disease	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Immune system disorders Vitamin D Deficiency	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations Otitis media	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations Upper Respiratory Infection	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations bacteriuria	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations conjunctivitis	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations fatigue	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations pharyngitis	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Infections and infestations urinary tract infections (UTI)	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) polyp colon	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders Anosmia	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders acute frontal lobe stroke	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders ageusia	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders amnesia	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders migraine	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Nervous system disorders worsening Parkinson's Disease	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Psychiatric disorders anxiety attack	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Renal and urinary disorders Colic Renal	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Renal and urinary disorders Nephrolithiasis Calcium Oxalate	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Reproductive system and breast disorders bacterial vaginosis	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders asthma with exacerbation	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders change in smell	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders cough	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders hemoptysis	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders hypoxia	0.00% 0/29 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders rhinitis	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders shortness of breath	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Respiratory, thoracic and mediastinal disorders sneezing	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Skin and subcutaneous tissue disorders thrush	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Surgical and medical procedures arthoplasty	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Surgical and medical procedures right shoulder arthroscopy, rotator cuff, repair	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.
Vascular disorders hypertension	3.4% 1/29 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 60 days.	0.00% 0/26 • Adverse Events were collected from baseline to end of study, approximately 60 days.