Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19 Disease

In brief

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.

Key facts

Study ID

NCT04417257

Run by

Laurent Pharmaceuticals Inc.

People needed

351

Starts

2020-08-18

Expected to finish

2024-05-30

Last updated by the study team

2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant exhibited symptoms [Extension Phase 3 study only: (including at least one lower respiratory symptom such as shortness of breath or dyspnea)] of COVID-19 disease at screening and/or since the start of their hospitalization (may have included treated symptoms)
• Participant was 18 years and older, of either gender
• Participant must have had 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 chronic obstructive pulmonary disease(COPD), asthma, emphysema
• Active [Extension Phase 3 study only: or a former smoker] with 20 pack-years of smoking history
• Obesity as depicted by BMI ≥30 kg/m2
• 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
• Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications
• 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]
• 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
• [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"]
• 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
• Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements
• Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study
• Participant was able to swallow the study drug capsules

You may not qualify if…

• Pregnancy or breastfeeding
• 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:
• 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 dialysis requirement
• Febrile neutropenia
• [Pilot Phase 2 study: Presence of active cancer treated with systemic chemotherapy or radiotherapy][Extension Phase 3 study: Presence of end-stage cancer]
• 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
• 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
• 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)]
• 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
• [Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours]

Where it is running

• 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

Full record on ClinicalTrials.gov

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