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NCT04676867

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

Completed Phase 2 Results posted Last updated 7 December 2022
What this trial tests

Phase 2 trial testing Dalcetrapib in Covid19 in 227 participants. Completed in 17 May 2021.

Timeline
11 January 2021
Primary endpoint
17 May 2021
17 May 2021

Quick facts

Lead sponsorDalCor Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment227
Start date11 January 2021
Primary completion17 May 2021
Estimated completion17 May 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

DalCor Pharmaceuticals

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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 was taken as the time from randomization until the first day of the last 72-hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved.

GroupValue95% CI
Placebo Tablets9.08.0 – 14.0
900 mg Dose9.08.0 – 10.0
1800 mg Dose9.58.0 – 14.0
3600 mg Dose10.09.0 – 11.0
Change From Baseline in log10 Viral Load (Saliva) Secondary · Screening/Baseline (Day -2 to Day -1), Day 3, Day 5, Day 10, and Day 28/End of Study (EOS)

Log10 viral load, as assessed using the saliva, was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, minimum, and maximum) for each visit as well as for changes from baseline where an 80% CI were also presented. A repeated ANCOVA model was used for the data shown below, showing the mean changes from baseline to study visits (Day 3, Day 5, Day 10, and Day 28/EOS) in log10 viral load including treatment groups by study visit interaction, baseline value of log10 viral load and baseline value of log10 viral load by study visit interaction.

Day 3
GroupValue95% CI
Placebo Tablets-0.77-1.04 – -0.49
900 mg Dose-0.79-1.04 – -0.54
1800 mg Dose-0.61-0.89 – -0.32
3600 mg Dose-0.79-1.07 – -0.51
Day 5
GroupValue95% CI
Placebo Tablets-1.45-1.72 – -1.18
900 mg Dose-1.50-1.76 – -1.25
1800 mg Dose-1.45-1.73 – -1.17
3600 mg Dose-1.27-1.55 – -0.99
Day 10
GroupValue95% CI
Placebo Tablets-3.43-3.79 – -3.08
900 mg Dose-3.24-3.55 – -2.92
1800 mg Dose-3.01-3.38 – -2.65
3600 mg Dose-3.23-3.61 – -2.85
Day 28/End of Study
GroupValue95% CI
Placebo Tablets-5.16-5.40 – -4.91
900 mg Dose-4.96-5.20 – -4.72
1800 mg Dose-5.30-5.57 – -5.03
3600 mg Dose-5.16-5.42 – -4.90
Change From Baseline in log10 Viral Load (Nasal Swab) Secondary · Screening/Baseline (Day -2 to Day -1), Day 3, Day 5, Day 10, and Day 28/End of Study (EOS)

Log10 viral load, as assessed using the nasal swab, was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, minimum, and maximum) for each visit as well as for changes from baseline where an 80% CI were also presented. A repeated ANCOVA model was used for the data shown below, showing the mean changes from baseline to study visits (Day 3, Day 5, Day 10, and Day 28/EOS) in log10 viral load including treatment groups by study visit interaction, baseline value of log10 viral load and baseline value of log10 viral load by study visit interaction.

Day 3
GroupValue95% CI
Placebo Tablets-0.94-1.18 – -0.71
900 mg Dose-1.17-1.39 – -0.94
1800 mg Dose-0.84-1.09 – -0.60
3600 mg Dose-0.92-1.17 – -0.68
Day 5
GroupValue95% CI
Placebo Tablets-1.87-2.15 – -1.60
900 mg Dose-2.25-2.53 – -1.98
1800 mg Dose-1.47-1.76 – -1.17
3600 mg Dose-2.00-2.29 – -1.71
Day 10
GroupValue95% CI
Placebo Tablets-4.76-5.08 – -4.45
900 mg Dose-4.42-4.72 – -4.11
1800 mg Dose-3.87-4.22 – -3.52
3600 mg Dose-4.23-4.59 – -3.87
Day 28/End of Study
GroupValue95% CI
Placebo Tablets-6.24-6.32 – -6.15
900 mg Dose-6.29-6.38 – -6.21
1800 mg Dose-6.26-6.36 – -6.17
3600 mg Dose-6.34-6.43 – -6.25
Time to Sustained Complete Clinical Resolution of Symptoms in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib Secondary · 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). The time to resolution was taken as the time from randomization until the first day of the last 72-hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" fr

GroupValue95% CI
Placebo Tablets28.016.0 – 28.0
900 mg Dose28.015.0 – 28.0
1800 mg Dose28.028.0 – 29.0
3600 mg Dose28.028.0 – 28.0
Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) Secondary · Day 1 to Day 28

Viral clearance based on polymerase chain reaction (PCR) test for Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) using nasal swab and saliva samples was performed on the intention-to-treat (ITT) population. Viral clearance was summarized by treatment group using Kaplan-Meier methods. Median and associated 80% confidence interval (CI) was presented. The number and percentage of patients who did not show viral clearance, did show viral clearance, and patients censored were presented.

Viral Clearance (saliva)
GroupValue95% CI
Placebo Tablets12
900 mg Dose10
1800 mg Dose9
3600 mg Dose14
Placebo Tablets41
900 mg Dose44
1800 mg Dose39
3600 mg Dose36
Viral Clearance (nasal swab)
GroupValue95% CI
Placebo Tablets25
900 mg Dose22
1800 mg Dose12
3600 mg Dose14
Placebo Tablets28
900 mg Dose32
1800 mg Dose36
3600 mg Dose36
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 Secondary · 28 days

Complete clinical resolution is defined as occurring when no key COVID-19 related symptom (excluding cough, sense of smell and taste) has a score higher than 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72 hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" was used. The symptoms are scored as on

GroupValue95% CI
Placebo Tablets28.028.0 – 29.0
900 mg Dose28.028.0 – 28.0
1800 mg Dose28.028.0 – 29.0
3600 mg Dose28.028.0 – 29.0
Time to Complete Clinical Resolution Secondary · 28 days

Sustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72 hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" was used. The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms wh

GroupValue95% CI
Placebo Tablets29.028.0 – 29.0
900 mg Dose28.028.0 – 29.0
1800 mg Dose29.028.0 – 29.0
3600 mg Dose28.528.0 – 29.0
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points Secondary · Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 14 (follow-up visit 1), and Day 28 (end of study / follow-up visit 2)

COVID-19 total symptom severity score was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, minimum, and maximum) for each visit as well as for changes from baseline where an 80% confidence interval (CI) was also presented. Mean changes from baseline were analyzed using a repeated measures ANCOVA model. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" from the Food and Drug Administration (FDA) document "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs

Baseline
GroupValue95% CI
Placebo Tablets10.70± 4.98
900 mg Dose11.11± 4.34
1800 mg Dose10.88± 4.63
3600 mg Dose9.02± 3.92
Day 2
GroupValue95% CI
Placebo Tablets10.30± 5.35
900 mg Dose10.76± 4.58
1800 mg Dose11.55± 4.29
3600 mg Dose11.39± 5.06
Change from baseline to Day 2
GroupValue95% CI
Placebo Tablets-0.40± 3.85
900 mg Dose-0.39± 3.52
1800 mg Dose0.68± 3.65
3600 mg Dose2.35± 3.90
Day 3
GroupValue95% CI
Placebo Tablets8.85± 4.79
900 mg Dose9.42± 4.53
1800 mg Dose10.57± 5.04
3600 mg Dose10.12± 5.40
Change from baseline to Day 3
GroupValue95% CI
Placebo Tablets-1.85± 3.78
900 mg Dose-1.69± 3.80
1800 mg Dose-0.38± 4.46
3600 mg Dose1.08± 4.71
Day 4
GroupValue95% CI
Placebo Tablets8.24± 5.13
900 mg Dose9.60± 5.09
1800 mg Dose10.75± 5.87
3600 mg Dose9.34± 5.39
Change from baseline to Day 4
GroupValue95% CI
Placebo Tablets-2.54± 5.04
900 mg Dose-1.55± 4.73
1800 mg Dose-0.13± 5.27
3600 mg Dose0.23± 5.03
Day 5
GroupValue95% CI
Placebo Tablets7.90± 4.97
900 mg Dose8.89± 5.56
1800 mg Dose9.29± 4.78
3600 mg Dose8.36± 4.50
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 Secondary · Screening (Day -2 to Day -1), Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28

The number and percentage of patients for each WHO clinical outcome score was summarized. Scores were compared using the Mann-Whitney-Wilcoxon test. This scale is called the "WHO Clinical Outcome Scale". It is scored from 0 to 9 where 9 is the most severe disease presentation. A higher score is a worse outcome.

Screening
GroupValue95% CI
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Placebo Tablets18
900 mg Dose15
1800 mg Dose19
3600 mg Dose23
Placebo Tablets35
900 mg Dose40
1800 mg Dose29
3600 mg Dose29
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Day 1
GroupValue95% CI
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Placebo Tablets15
900 mg Dose13
1800 mg Dose17
3600 mg Dose18
Placebo Tablets38
900 mg Dose42
1800 mg Dose31
3600 mg Dose34
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Day 3
GroupValue95% CI
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Placebo Tablets18
900 mg Dose16
1800 mg Dose15
3600 mg Dose19
Placebo Tablets35
900 mg Dose38
1800 mg Dose32
3600 mg Dose25
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Day 5
GroupValue95% CI
Placebo Tablets0
900 mg Dose0
1800 mg Dose1
3600 mg Dose0
Placebo Tablets17
900 mg Dose21
1800 mg Dose12
3600 mg Dose19
Placebo Tablets34
900 mg Dose31
1800 mg Dose29
3600 mg Dose27
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
End of Treatment (Day 10)
GroupValue95% CI
Placebo Tablets3
900 mg Dose5
1800 mg Dose5
3600 mg Dose1
Placebo Tablets29
900 mg Dose27
1800 mg Dose19
3600 mg Dose18
Placebo Tablets19
900 mg Dose20
1800 mg Dose22
3600 mg Dose31
Placebo Tablets1
900 mg Dose0
1800 mg Dose1
3600 mg Dose0
Follow-up visit 1 (Day 14)
GroupValue95% CI
Placebo Tablets10
900 mg Dose14
1800 mg Dose12
3600 mg Dose13
Placebo Tablets31
900 mg Dose21
1800 mg Dose23
3600 mg Dose24
Placebo Tablets11
900 mg Dose18
1800 mg Dose8
3600 mg Dose11
Placebo Tablets0
900 mg Dose1
1800 mg Dose0
3600 mg Dose0
Follow-up visit 2 (Day 28/End Of Study)
GroupValue95% CI
Placebo Tablets28
900 mg Dose21
1800 mg Dose19
3600 mg Dose19
Placebo Tablets20
900 mg Dose21
1800 mg Dose21
3600 mg Dose24
Placebo Tablets5
900 mg Dose12
1800 mg Dose5
3600 mg Dose8
Placebo Tablets0
900 mg Dose0
1800 mg Dose0
3600 mg Dose0
Rate of Hospitalization Through Day 28 Secondary · Day 1 to Day 28

The analysis of this endpoint was performed on the intention-to-treat (ITT) population. The percentage of patients who were hospitalized was compared using a binary logistic regression analysis. The model included only the treatment group. The results were presented as odds ratios, with associated 80% CIs and p-value.

GroupValue95% CI
Placebo Tablets2
900 mg Dose4
1800 mg Dose3
3600 mg Dose1
Placebo Tablets51
900 mg Dose51
1800 mg Dose45
3600 mg Dose51
Rate of Progression to Oxygen Therapy Through Day 28 Secondary · Day 1 to Day 28

The analysis of this endpoint was performed on the intention-to-treat (ITT) population. The number and percentage of patients who progressed to oxygen therapy was presented. The percentage of patients who had progressed to oxygen therapy was compared using a binary logistic regression analysis. The model included only the treatment group. The results were presented as odds ratios, with associated 80% confidence intervals (CIs) and p-value.

GroupValue95% CI
Placebo Tablets1
900 mg Dose4
1800 mg Dose2
3600 mg Dose1
Placebo Tablets52
900 mg Dose51
1800 mg Dose46
3600 mg Dose51
Type of Oxygen Therapy Received Through Day 28 Secondary · Day 1 to Day 28

The analysis of this endpoint was performed on the intention-to-treat (ITT) population and only on those who received oxygen therapy. The number and percentage of patients who received different types of oxygen therapy was presented using descriptive statistics.

GroupValue95% CI
Placebo Tablets1
900 mg Dose4
1800 mg Dose1
3600 mg Dose1
Placebo Tablets0
900 mg Dose0
1800 mg Dose1
3600 mg Dose0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Tablets
Serious: 2/53 (4%)
Deaths: 0/53
900 mg Dose
Serious: 4/55 (7%)
Deaths: 0/55
1800 mg Dose
Serious: 4/48 (8%)
Deaths: 1/48
3600 mg Dose
Serious: 1/52 (2%)
Deaths: 0/52

Serious adverse events (7 terms)

ReactionSystemPlacebo Tablets900 mg Dose1800 mg Dose3600 mg Dose
Respiratory distressRespiratory, thoracic and mediastinal disorders————
PneumoniaInfections and infestations————
Proctitis ulcerativeGastrointestinal disorders————
AstheniaGeneral disorders————
Pulmonary embolismRespiratory, thoracic and mediastinal disorders————
Rash maculopapularRespiratory, thoracic and mediastinal disorders————
Deep vein thrombosisVascular disorders————
Other adverse events (8 terms — click to expand)

ReactionSystemPlacebo Tablets900 mg Dose1800 mg Dose3600 mg Dose
DiarrheaGastrointestinal disorders————
Gastrointestinal disorderGastrointestinal disorders————
Laboratory test abnormalInvestigations————
RashSkin and subcutaneous tissue disorders————
Feces softGastrointestinal disorders————
Gastric disorderGastrointestinal disorders————
Respiratory distressRespiratory, thoracic and mediastinal disorders————
NauseaGastrointestinal disorders————

Most-reported serious reactions: Respiratory distress, Pneumonia, Proctitis ulcerative, Asthenia, Pulmonary embolism, Rash maculopapular, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT04676867 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Investigating Lipid-Modulating Agents for Prevention or Treatment of COVID-19: JACC State-of-the-Art Review.
    Talasaz AH, Sadeghipour P, Aghakouchakzadeh M, Dreyfus I, et al · · 2021 · cited 43× · PMID 34649702 · DOI 10.1016/j.jacc.2021.08.021
  2. Inhibition of the 3CL Protease and SARS-CoV-2 Replication by Dalcetrapib.
    Niesor EJ, Boivin G, Rhéaume E, Shi R, et al · · 2021 · cited 21× · PMID 34235330 · DOI 10.1021/acsomega.1c01797
  3. The Role of High-Density Lipoprotein in COVID-19.
    Wang G, Deng J, Li J, Wu C, et al · · 2021 · cited 19× · PMID 34335279 · DOI 10.3389/fphar.2021.720283
  4. Recent advances in small-molecular therapeutics for COVID-19.
    Zhong L, Zhao Z, Peng X, Zou J, et al · · 2022 · cited 15× · PMID 36268466 · DOI 10.1093/pcmedi/pbac024
  5. Lipid-Modulating Agents for Prevention or Treatment of COVID-19 in Randomized Trials
    Talasaz AH, Sadeghipour P, Aghakouchakzadeh M, Dreyfus I, et al · · 2021 · DOI 10.1101/2021.05.03.21256468

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