Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults
NCT ID: NCT04417257
Last Updated: 2025-11-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
351 participants
INTERVENTIONAL
2020-08-18
2024-05-30
Brief Summary
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Detailed Description
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The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care relative to placebo + standard-of-care in participants with COVID-19 Disease with confirmed SARS-CoV-2 infection. SARS is "severe acute respiratory syndrome". CoV is " Coronavirus".
The purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized participants 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LAU-7b
Active drug as LAU-7b capsules
LAU-7b
LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
Placebo
Placebo oral capsule (as inactive capsules identical to active arm)
Placebo oral capsule
Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
Interventions
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LAU-7b
LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
Placebo oral capsule
Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant was 18 years and older, of either gender
3. Participant must have had at least one of the following factors/co-morbidities:
1. Controlled or uncontrolled diabetes
2. Pre-existing cardiovascular disease, including hypertension
3. Pre-existing respiratory disease such as chronic obstructive pulmonary disease(COPD), asthma, emphysema
4. Active \[Extension Phase 3 study only: or a former smoker\] with 20 pack-years of smoking history
5. Obesity as depicted by BMI ≥30 kg/m2
6. Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin \>1.5 the upper limit of normal (ULN), \[Extension Phase 3 study only: D-dimer \>3.0 ULN\] and/or C reactive protein (CRP) \>1.5 ULN
7. Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications
4. Participant had a documented positive test for the SARS-CoV-2 virus \[Pilot Phase 2 study only: or was suspected to be positive and with a test result pending\]. \[Extension Phase 3 study only: Co-infection with other viral respiratory infections was allowed and had to be documented in medical history\]
5. Participant was under observation by, or admitted to, a controlled facility or hospital \[Extension Phase 3 study only: for no more than 48 hours (72 hours from amendment 3 onwards) before screening, including any prior stay in another hospital\] to receive standard of care (SoC) for COVID-19 disease
6. \[Pilot Phase 2 study only: Participant's hs was 3, 4, or 5 on the WHO ordinal scale and not previously a "6"\] \[Extension Phase 3 study only: 3 or 4 on the World Health Organization (WHO) ordinal scale and not previously a "5 or a 6"\]
7. If female, participant was either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who were capable of conception had to be practicing a highly effective method of birth control (acceptable methods included 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 was not classified as an effective method of birth control. A pregnancy test had to be negative at the Screening Visit
8. Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements
9. Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study
10. Participant was able to swallow the study drug capsules
Exclusion Criteria
2. Health condition deemed to possibly interfere with the study endpoints and/or the safety of the participants. For example, the following conditions were considered contraindicated for participation in the study, but this was not an exhaustive list. In case of doubt, the investigator was to consult with the Sponsor's medical representative:
1. Presence of inherited retinitis pigmentosa
2. Presence or history of liver failure (Child-Pugh B or C)
3. Presence or history of stage 4 severe chronic kidney disease or dialysis requirement
4. Febrile neutropenia
5. \[Pilot Phase 2 study: Presence of active cancer treated with systemic chemotherapy or radiotherapy\]\[Extension Phase 3 study: Presence of end-stage cancer\]
3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation used in the study
4. Participation in another drug clinical trial within 30 days (or a minimum of 5 t½) prior to screening, except ongoing participation in non-interventional studies
5. Calculated creatinine clearance (CrCl), using the Cockroft-Gault equation for example \[Pilot Phase 2 study: \<60 mL/min\] \[Extension Phase 3 study: \<30 mL/min)\]
6. Presence of total bilirubin \>1.5 x ULN (in the absence of demonstrated Gilbert's syndrome), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2.5 x ULN
7. \[Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours\]
18 Years
ALL
No
Sponsors
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Laurent Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Marie Houle, PhD
Role: STUDY_DIRECTOR
Laurent Pharmaceuticals Inc.
Locations
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Chandler Regional Medical Center / Mercy Gilbert Medical Center
Chandler, Arizona, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Nuvance Health - Danbury Hospital
Danbury, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Medical Center Beaches
Jacksonville Beach, Florida, United States
St Lukes Hospital
Boise, Idaho, United States
NorthShore University Health System - Swedish Hospital
Chicago, Illinois, United States
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion
Annapolis, Maryland, United States
Wayne State University, Harper University Hospital and Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Staten Island University Hospital North
Staten Island, New York, United States
Wake Forest University Health Science
Winston-Salem, North Carolina, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Kettering Health
Kettering, Ohio, United States
Robert Packer Hospital
Sayre, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
PRX Research /Dallas Regional Medical Center
Mesquite, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi
Chicoutimi, Quebec, Canada
CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CISSS Des Laurentides
Saint-Jérôme, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol: Pilot Phase 2 Protocol
Document Type: Study Protocol: Phase 3 Extension Protocol
Document Type: Statistical Analysis Plan: Pilot Phase 2 portion Final Analysis Plan
Document Type: Statistical Analysis Plan: Pilot Phase 2 Interim Futility Analysis Plan
Document Type: Statistical Analysis Plan: Phase 3 Extension Final Analysis Plan
Document Type: Statistical Analysis Plan: Phase 3 Interim sample size re-estimation/futility SAP
Document Type: Statistical Analysis Plan: Phase 3 Statistical Analysis Plan Addendum
Other Identifiers
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LAU-20-01
Identifier Type: -
Identifier Source: org_study_id