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Trial record 1 of 1 for:    NCT04676867
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Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT04676867
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
The Montreal Health Innovations Coordinating Center (MHICC)
Covance
Information provided by (Responsible Party):
DalCor Pharmaceuticals

Brief Summary:
This study is a placebo-controlled, Phase 2a proof-of-concept clinical study which will evaluate efficacy and safety of dalcetrapib in outpatients patients with mild to moderate, symptomatic, confirmed COVID 19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Dalcetrapib Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, double blind, multicenter, Phase 2a proof-of-concept study in outpatients with confirmed, mild to moderate, symptomatic COVID-19.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double blind study.
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Phase 2a Proof-of-concept Trial of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: 900 mg dose
Patients will receive Dalcetrapib 900 mg for 10 days
Drug: Dalcetrapib
Dalcetrapib 300 mg Film-Coated Tablets

Active Comparator: 1800 mg dose
Patients will receive Dalcetrapib 1800 mg for 10 days
Drug: Dalcetrapib
Dalcetrapib 300 mg Film-Coated Tablets

Active Comparator: 3600 mg dose
Patients will receive Dalcetrapib 3600 mg for 10 days
Drug: Dalcetrapib
Dalcetrapib 300 mg Film-Coated Tablets

Placebo Comparator: Placebo tablets
Patients will receive Placebo for 10 days
Other: Placebo
Placebo Tablets




Primary Outcome Measures :
  1. To evaluate the time to sustained clinical resolution of symptoms of COVID-19 [ Time Frame: 28 Days ]
    Sustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 1 over a 72-hour period (as documented using an electronic patient-reported outcome [ePRO] instrument), except for sense of smell and taste where the score should be 0 over a 72-hour period. The time to resolution will be taken as the time from randomization until the first day of the last 72 hour period where the patient meets the definition of resolution within 28 days. Patients who do not meet the definition of resolution 28 days after randomization will be considered not resolved.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must satisfy all of the following criteria unless otherwise stated:

    1. Willing and able to provide informed consent
    2. Male or female patients > 18 years of age on the day of informed consent
    3. Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as assessed by PCR or point-of-care within 72 hours of first dose on Day 1
    4. Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of first dose on Day 1, at least two of the following symptoms:

      • stuffy or runny nose
      • sore throat
      • shortness of breath
      • cough
      • fatigue
      • myalgia
      • headache
      • chills or shivering
      • feeling hot or feverish
      • nausea
      • vomiting
      • diarrhea
      • anosmia
      • ageusia
    5. Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3])
    6. Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the ICF.

Exclusion Criteria:

  • Patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated:

    1. Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding
    2. Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception
    3. Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO])
    4. Expected survival less than 72 hours
    5. Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air
    6. Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently
    7. History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the Investigator
    8. Use of any other concurrent investigational drugs while participating in the present study
    9. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions)
    10. Known renal disease with an estimated glomerular filtration rate (eGFR) <50 mL/min based on local laboratory results
    11. Patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
    12. Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results
    13. Co administration of clinical doses of orlistat with dalcetrapib
    14. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening
    15. Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study
    16. History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676867


Contacts
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Contact: David Kallend +41 79 174 1830 dkallend@dalcorpharma.com
Contact: Marianne Rufiange 514-461-1300 ext 2036 Marianne.Rufiange@mhicc.org

Locations
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Canada, Quebec
Institut de Cardiologie de Montréal Recruiting
Montréal, Quebec, Canada, H1T 1C8
Contact: Jean C. Gregoire         
Principal Investigator: Jean C. Gregoire         
Sponsors and Collaborators
DalCor Pharmaceuticals
The Montreal Health Innovations Coordinating Center (MHICC)
Covance
Investigators
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Study Director: David Kallend DalCor Pharmaceuticals
Additional Information:
Publications:
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Responsible Party: DalCor Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04676867    
Other Study ID Numbers: DAL-401
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DalCor Pharmaceuticals:
COVID-19
Coronavirus disease
Dalcetrapib
Additional relevant MeSH terms:
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Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents