Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Males and females, at least 18 years of age, capable and willing to provide informed
consent;
- Patient must have received a diagnosis of COVID-19 infection within the last 3 days;
- Outpatient setting (not currently hospitalized);
- Patient must possess at least one of the following high-risk criteria: 60 years or
more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension
(systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma,
chronic obstructive pulmonary disease, or present or past smoking), known heart
failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at
the time of presentation, the combination of high neutrophil count and low lymphocyte
count;
- Female patient is either not of childbearing potential, defined as postmenopausal for
at least 1 year or surgically sterile, or is of childbearing potential and practicing
at least one method of contraception and preferably two complementary forms of
contraception including a barrier method (e.g. male or female condoms, spermicides,
sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study
and for 30 days after study completion;
- Patient or their caregiver must be able and willing to comply with the requirements of
this study protocol.
Exclusion Criteria:
- Patient currently hospitalized or under immediate consideration for hospitalization;
- Patient currently in shock or with hemodynamic instability;
- Patient with severe hepatic disease (as per clinical judgement) and liver enzymes >10x
the upper limit of normal;
- Female patient who is pregnant, breast-feeding, or is considering becoming pregnant
during the study or for 1 day after the last dose of study medication;
- Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other
indications (mainly chronic indications represented by organ transplantation or
autoimmune diseases);
- On Warfarin therapy;
- Patient with a history of an allergic reaction or significant sensitivity to Fisetin;
- Patient undergoing chemotherapy for cancer;
- Patient is considered by the investigator, for any reason, to be an unsuitable study
candidate.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Eligibility last updated 6/8/22. Questions regarding updates should be directed to the study team contact.