Phase
Condition
Covid-19
Treatment
LAU-7b
Placebo oral capsule
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must exhibit symptoms (including at least one lower respiratory symptomsuch as shortness of breath or dyspnea) of COVID-19 disease at screening and/orsince the start of their hospitalization (may include treated symptoms;
Subjects must be 18 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 or a former smoker with a 20 pack-years of smoking history;
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, D-dimer >3.0 upper limit of normaland/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;
Subjects must be under observation by, or admitted to a controlled facility orhospital to receive standard-of-care for COVID-19 disease (care for COVID-19 diseaseshould be for no more than 72 hours before screening, including any prior stay inanother hospital);
Subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5or a 6";
If female, must be either post-menopausal (one year or greater without menses),surgically sterile, or, for female subjects of child-bearing potential who arecapable of conception, must be: practicing a highly effective method of birthcontrol (acceptable methods include intrauterine device, complete abstinence,spermicide + barrier, male partner surgical sterilization, or hormonalcontraception) during the study and through 30 days after the last dose of the studymedication. Periodical abstinence is not classified as an effective method of birthcontrol. A pregnancy test must be negative at the Screening Visit;
Subjects must have the ability to understand and give informed consent, which can beverbal with a witness, according to local requirements;
Subjects deemed capable of adequate compliance including attending scheduled visitsfor the duration of the study;
Subjects must be able to swallow the study drug capsules.
Exclusion
Exclusion Criteria:
Pregnancy or breastfeeding;
Health condition deemed to possibly interfere with the study endpoints and/or thesafety of the patients. For example, the following conditions should be consideredcontraindicated for participation in the study, but this is not an exhaustive list.In case of doubt, the Investigator should consult with the sponsor's medicalrepresentative:
Presence of inherited retinitis pigmentosa;
Presence or history of liver failure (Child-Pugh B or C);
Presence or history of stage 4 severe chronic kidney disease or dialysisrequirement;
Febrile neutropenia;
Presence of end-stage cancer.
Known history of a severe allergy or sensitivity to retinoids, or with knownallergies to excipients in the oral capsule formulation proposed to be used in thestudy;
Participation in another drug clinical trial within 30 days (or a minimum of 5elimination half-lives) prior to screening, except ongoing participation innon-interventional studies;
Calculated creatinine clearance (CrCL, using the Cockroft-Gault equation forexample) <50 ml/min;
Presence of total bilirubin >1.5 x ULN (in the absence of demonstrated Gilbert'ssyndrome), ALT and/or AST > 2.5 x ULN;
Patient expected to be transferred to ICU or die in the next 24 hours.
Study Design
Study Description
Connect with a study center
St-Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi
Chicoutimi, Quebec G7H 5H6
CanadaSite Not Available
CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont
Montréal, Quebec H1T 2M4
CanadaSite Not Available
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec H2X2P1
CanadaSite Not Available
Jewish General Hospital
Montréal, Quebec H3T 1E2
CanadaSite Not Available
McGill University Health Centre
Montréal, Quebec H4A 3J1
CanadaSite Not Available
CISSS Des Laurentides
Saint-Jérôme, Quebec J7Z 5T3
CanadaSite Not Available
Chandler Regional Medical Center / Mercy Gilbert Medical Center
Chandler, Arizona 85224
United StatesSite Not Available
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesSite Not Available
University of California Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Nuvance Health - Danbury Hospital
Danbury, Connecticut 06810
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Baptist Medical Center Beaches
Jacksonville Beach, Florida 32250
United StatesSite Not Available
St Lukes Hospital
Boise, Idaho 83702
United StatesSite Not Available
NorthShore University Health System - Swedish Hospital
Chicago, Illinois 60625
United StatesSite Not Available
NorthShore University Health System - Glenbrook Hospital
Evanston, Illinois 60201
United StatesSite Not Available
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois 60026
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Rapides Regional Medical Center
Alexandria, Louisiana 71301
United StatesSite Not Available
University Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion
Annapolis, Maryland 21401
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Wayne State University, Harper University Hospital and Detroit Receiving Hospital
Detroit, Michigan 48201
United StatesSite Not Available
Mercy Research
Creve Coeur, Missouri 63141
United StatesSite Not Available
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United StatesSite Not Available
Staten Island University Hospital North
Staten Island, New York 10305
United StatesSite Not Available
Wake Forest University Health Science
Winston-Salem, North Carolina 27157
United StatesSite Not Available
OhioHealth Riverside Methodist Hospital
Columbus, Ohio 43214
United StatesSite Not Available
Kettering Health
Kettering, Ohio 45429
United StatesSite Not Available
Robert Packer Hospital
Sayre, Pennsylvania 18840
United StatesSite Not Available
Roper St. Francis Healthcare
Charleston, South Carolina 29414
United StatesSite Not Available
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
PRX Research /Dallas Regional Medical Center
Mesquite, Texas 75149
United StatesSite Not Available
University of Utah Health
Salt Lake City, Utah 84112
United StatesSite Not Available
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