Study of LAU-7b for the Treatment of COVID-19 Disease in Adults

Last updated: July 29, 2024
Sponsor: Laurent Pharmaceuticals Inc.
Overall Status: Completed

Phase

2/3

Condition

Covid-19

Treatment

LAU-7b

Placebo oral capsule

Clinical Study ID

NCT04417257
LAU-20-01
  • Ages > 18
  • All Genders

Study Summary

A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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;

  2. Subjects must be 18 years and older, of either gender;

  3. Subjects must have at least one of the following factors/co-morbidities:

  4. Controlled or uncontrolled diabetes;

  5. Pre-existing cardiovascular disease, including hypertension;

  6. Pre-existing respiratory disease such as COPD, asthma, emphysema;

  7. Active or a former smoker with a 20 pack-years of smoking history;

  8. Obesity as depicted by body mass index ≥ 30;

  9. 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

  10. Patient aged 70 years and older who, based on the judgment of the Investigator,is at a higher risk of developing complications.

  11. Subjects must have a documented positive test for the SARS-CoV-2 virus;

  12. 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);

  13. Subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5or a 6";

  14. 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;

  15. Subjects must have the ability to understand and give informed consent, which can beverbal with a witness, according to local requirements;

  16. Subjects deemed capable of adequate compliance including attending scheduled visitsfor the duration of the study;

  17. Subjects must be able to swallow the study drug capsules.

Exclusion

Exclusion Criteria:

  1. Pregnancy or breastfeeding;

  2. 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:

  3. Presence of inherited retinitis pigmentosa;

  4. Presence or history of liver failure (Child-Pugh B or C);

  5. Presence or history of stage 4 severe chronic kidney disease or dialysisrequirement;

  6. Febrile neutropenia;

  7. Presence of end-stage cancer.

  8. 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;

  9. 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;

  10. Calculated creatinine clearance (CrCL, using the Cockroft-Gault equation forexample) <50 ml/min;

  11. Presence of total bilirubin >1.5 x ULN (in the absence of demonstrated Gilbert'ssyndrome), ALT and/or AST > 2.5 x ULN;

  12. Patient expected to be transferred to ICU or die in the next 24 hours.

Study Design

Total Participants: 125
Treatment Group(s): 2
Primary Treatment: LAU-7b
Phase: 2/3
Study Start date:
June 29, 2020
Estimated Completion Date:
May 30, 2024

Study Description

RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 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.

Connect with a study center

  • St-Paul's Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont

    Montréal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec H2X2P1
    Canada

    Site Not Available

  • Jewish General Hospital

    Montréal, Quebec H3T 1E2
    Canada

    Site Not Available

  • McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • CISSS Des Laurentides

    Saint-Jérôme, Quebec J7Z 5T3
    Canada

    Site Not Available

  • Chandler Regional Medical Center / Mercy Gilbert Medical Center

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Nuvance Health - Danbury Hospital

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Baptist Medical Center Beaches

    Jacksonville Beach, Florida 32250
    United States

    Site Not Available

  • St Lukes Hospital

    Boise, Idaho 83702
    United States

    Site Not Available

  • NorthShore University Health System - Swedish Hospital

    Chicago, Illinois 60625
    United States

    Site Not Available

  • NorthShore University Health System - Glenbrook Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • NorthShore University Health System - Glenbrook Hospital

    Glenview, Illinois 60026
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Rapides Regional Medical Center

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • University Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Wayne State University, Harper University Hospital and Detroit Receiving Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Mercy Research

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Staten Island University Hospital North

    Staten Island, New York 10305
    United States

    Site Not Available

  • Wake Forest University Health Science

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Kettering Health

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Robert Packer Hospital

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Roper St. Francis Healthcare

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • PRX Research /Dallas Regional Medical Center

    Mesquite, Texas 75149
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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