Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.