Phase 2
Completed N=225
Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Source: ClinicalTrials.gov NCT04676867 ↗Enrolled (actual)
225
Serious AEs
5.3%
Results posted
Dec 2022
Primary outcomePrimary: Time to Sustained Clinical Resolution of Symptoms of COVID-19 (Excluding Cough, Sense of Smell and Taste) in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib — 9.0; 9.0; 9.5; 10.0 days — p=0.2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sustained Clinical Resolution of Symptoms of COVID-19 (Excluding Cough, Sense of Smell and Taste) in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib |
9.0; 9.0; 9.5; 10.0 | 0.2 |
| SECONDARY Change From Baseline in log10 Viral Load (Saliva) |
-0.77; -0.79; -0.61; -0.79; -1.45; -1.50 | 0.2 |
| SECONDARY Change From Baseline in log10 Viral Load (Nasal Swab) |
-0.94; -1.17; -0.84; -0.92; -1.87; -2.25 | 0.2 |
| SECONDARY Time to Sustained Complete Clinical Resolution of Symptoms in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib |
28.0; 28.0; 28.0; 28.0 | 0.2 |
| SECONDARY Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) |
12; 10; 9; 14; 41; 44 | 0.2 |
| SECONDARY Time to Complete Clinical Resolution (Excluding Cough, Sense of Smell and Taste) Defined in the Same Way as the Primary Endpoint, But Considering That All Symptoms Must Resolve to a Score of 0 for 72 Hours |
28.0; 28.0; 28.0; 28.0 | 0.2 |
| SECONDARY Time to Complete Clinical Resolution |
29.0; 28.0; 29.0; 28.5 | 0.2 |
| SECONDARY Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points |
10.70; 11.11; 10.88; 9.02; 10.30; 10.76 | 0.2 |
| SECONDARY Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28 |
0; 0; 0; 0; 18; 15 | 0.2 |
| SECONDARY Rate of Hospitalization Through Day 28 |
2; 4; 3; 1; 51; 51 | 0.2 |
| SECONDARY Rate of Progression to Oxygen Therapy Through Day 28 |
1; 4; 2; 1; 52; 51 | 0.2 |
| SECONDARY Type of Oxygen Therapy Received Through Day 28 |
1; 4; 1; 1; 0; 0 | — |
| SECONDARY Duration of Hospitalization |
3.0; 5.75; 8.67; 3.0 | 0.2 |
| SECONDARY Mortality Rate by Day 28 |
53; 55; 47; 52; 0; 0 | 0.2 |
Eligibility Criteria
Inclusion Criteria
- Patients must satisfy all of the following criteria unless otherwise stated:
- Willing and able to provide informed consent
- Male or female patients > 18 years of age on the day of informed consent
- 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
- 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
- Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3])
- 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:
- Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding
- 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
- 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])
- Expected survival less than 72 hours
- Peripheral capillary oxygen saturation (SpO2) 4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions)
- Known renal disease with an estimated glomerular filtration rate (eGFR) 3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results
- Co administration of clinical doses of orlistat with dalcetrapib
- Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening
- 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
- History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.
Data sourced from ClinicalTrials.gov (NCT04676867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.