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

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Laurent Pharmaceuticals Inc.
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Updated on 5 August 2020
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Summary

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.

Details
Condition COVID-19 Disease
Age 45years - 100years
Treatment Placebo Oral Capsule, LAU-7b
Clinical Study IdentifierNCT04417257
SponsorLaurent Pharmaceuticals Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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