Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2021-05-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, double blind, multicenter, Phase 2a proof-of-concept study in outpatients with confirmed, mild to moderate, symptomatic COVID-19.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double blind study.

Study Groups

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900 mg dose

Patients will receive Dalcetrapib 900 mg for 10 days

Group Type ACTIVE_COMPARATOR

Dalcetrapib

Intervention Type DRUG

Dalcetrapib 300 mg Film-Coated Tablets

1800 mg dose

Patients will receive Dalcetrapib 1800 mg for 10 days

Group Type ACTIVE_COMPARATOR

Dalcetrapib

Intervention Type DRUG

Dalcetrapib 300 mg Film-Coated Tablets

3600 mg dose

Patients will receive Dalcetrapib 3600 mg for 10 days

Group Type ACTIVE_COMPARATOR

Dalcetrapib

Intervention Type DRUG

Dalcetrapib 300 mg Film-Coated Tablets

Placebo tablets

Patients will receive Placebo for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Tablets

Interventions

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Dalcetrapib

Dalcetrapib 300 mg Film-Coated Tablets

Intervention Type DRUG

Placebo

Placebo Tablets

Intervention Type OTHER

Eligibility Criteria

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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 informed consent form (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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No