Overview
A randomized, double-blind, placebo-controlled Phase 2 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.
Description
RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study of LAU-7b for the treatment of COVID-19 Disease in patients at a higher risk than the general COVID-19 Disease population to develop complications while hospitalized.
The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care relative to placebo + standard-of-care in patients with COVID-19 Disease with confirmed SARS-CoV-2 infection.
The purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized patients including aggravation such as recourse to mechanical ventilation and death.
The means are the direct effects of LAU-7b on the resolution of inflammation, interference with viral proliferation and protection from excessive pro-inflammatory response.
Eligibility
Inclusion Criteria:
- Subjects must exhibit symptoms of COVID-19 disease at screening;
- Subjects must be 45 years and older, of either gender;
- Subjects must have at least one of the following factors/co-morbidities:
- Controlled or uncontrolled diabetes;
- Pre-existing cardiovascular disease, including hypertension;
- Pre-existing respiratory disease such as COPD, asthma, emphysema;
- Active smoker with a 20 pack-years of smoking;
- Obesity as depicted by body mass index 30;
- Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin >1.5 upper limit of normal and/or CRP >1.5 upper limit of normal
- Patient aged 70 years and older who, based on the judgment of the Investigator, is at a higher risk of developing complications.
- Subjects must have a documented positive test for the SARS-CoV-2 virus or be suspected to be positive and with a test result pending;
- Subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for COVID-19 disease;
- Subject's health status must be 3 or 4 on the ordinal scale;
- If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence is not classified as an effective method of birth control. A pregnancy test must be negative at the Screening Visit;
- Subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements;
- Subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study;
- Subjects must be able to swallow the study drug capsules.
Exclusion Criteria:
- Pregnancy or breastfeeding;
- Health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. For example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. In case of doubt, the Investigator should consult with the sponsor's medical representative
- Presence of inherited retinitis pigmentosa;
- Presence or history of liver failure;
- Presence or history of stage 4 severe chronic kidney disease or dialysis requirement;
- Febrile neutropenia;
- Presence of active cancer treated with systemic chemotherapy or radiotherapy.
- Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study;
- Participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies;
- Patient with known renal or hepatic impairment or patient with serum creatinine above 1.5 x upper limit of normal for each gender, as a marker of significant renal impairment, or an ALT and/or AST above 5 x the upper limit of normal, as a marker of significant hepatic impairment.