COVID-19 InfectionPhase 2/3NCT04894266
An Open-Label Study of Apabetalone in Covid Infection
A Phase 2/3 study testing Apabetalone in people with COVID-19 Infection, run by Resverlogix Corp at 1 site in Canada.
Trial summary
The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Apabetalone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2022to 22 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent before participation in the study.
- Aged ≥18 years
- Hospital admission with symptoms suggestive of COVID-19 infection
- Ten days or less since the onset of symptoms
- Virological confirmation of SARS-CoV2 infection by reverse transcriptase PCR (RT- PCR) according to Center for Disease Control and Prevention (CDC) guidelines within the previous 72 hours
- Subjects showing bilateral pulmonary infiltrates on chest imaging
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- Saturation of oxygen (SpO2) by pulse oximetry <94% on room air at sea level.
- Female subjects must meet one of the following:
- If of childbearing potential, female subjects must have a negative urine pregnancy test at screening and must also be willing to practice total abstinence or to use an approved (non-hormonal) form of birth-control throughout the study treatment phase and up to 28 days after the last study drug dose if randomized to apabetalone." -OR-
- Meet at least one of the following criteria:
- Be postmenopausal, defined as having been amenorrheic for at least 2 years
- Have had a hysterectomy or a bilateral oophorectomy
Who cannot join
- Subjects with SpO2 >94% on room air using pulse oximetry and without bilateral infiltrates on chest imaging
- Subjects requiring mechanical ventilation or extracorporeal membrane oxygenation
- Patients with Stage 5 CKD receiving renal replacement therapy with either hemodialysis or peritoneal dialysis, renal transplant or with eGFR <15 mL/min/1.73 m2.
- Patients with prior transplantations of organs or bone marrow.
- Patients with unstable cardiac condition including heart attack, stroke, uncontrolled atrial fibrillation or a major cardiac procedure within 3 months as assessed by the investigator.
- New York Heart Association Class IV congestive heart failure.
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- Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure.
- ALT or AST >5 x ULN on admission laboratory assessment.
- Total bilirubin >2 x ULN on admission laboratory assessment.
- Have received any live attenuated vaccine within 90 days at dosing.
- Known human immunodeficiency virus positive patients.
- Chronic use of oxygen therapy at home
- Have participated in a clinical study and received any investigational medication within the last 30 days preceding Visit 1 (Screening).
- Subjects whose safety may be compromised by study participation
- Are not, in the opinion of the investigator, able or willing to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Safety and Effect on Clinical Course and Key Biomarkers of Oral Apabetalone in Hospitalized Subjects With Covid-19 Infection in Addition to Standard of Care (SOC)
The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection
Read the detailed description
Primary Objective:
The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection
Secondary Objectives:
To evaluate the effect of apabetalone on biomarkers of inflammation (interleukin [IL]-6, IL-8, tumor necrosis factor [TNF]-α and C-reactive protein [CRP]) To evaluate the effect of apabetalone on key virus-related biomarkers including ACE2, serine protease inhibitor Clade A Member 8 (SERPINA8), angiotension (Ang) II and Ang (1-7) and others within the renin-angiotensin system (RAS) To evaluate the effect of apabetalone on clinical laboratory parameters including white blood cell (WBC) count, platelet count, D-Dimer, ferritin and clotting time in hospitalized subjects with Covid-19 infection To evaluate the effect of apabetalone cardiac and renal biomarkers including N-terminal pro B-type natriuretic peptide (NT-proBNP), troponin and Cystatin C To evaluate changes in viral levels measured via oropharyngeal or nasopharyngeal swabs To evaluate the effect of apabetalone on rate of admission to ICU, need for mechanical ventilation/ECMO, and death To evaluate the safety of apabetalone in hospitalized subjects with Covid-19 Infection
- Conditions
- COVID-19 Infection
- Being tested
- Apabetalone, Standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApabetaloneDrug
Apabetalone 100mg BID
Standard of careOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | All subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital. Receives: Other: Standard of care |
| Standard of Care plus apabetalone | Experimental | All subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital. For the apabetalone cohort, treatment will be administered BID with meals. Receives: Drug: Apabetalone; Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
Measured: Change in WHO Ordinal Scale for Clinical Improvement at Day 14
Secondary outcomes (5)
Change in WHO Ordinal Scale for Clinical Improvement at Day 28
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
Measured: Study Day 28
Biomarkers of inflammation Interleukin-6
Interleukin-6 is a biomarker of inflammation
Measured: Study Day 28
Total time of hospitalization
Total time of hospitalization
Measured: through study completion, an average of 28 days
Biomarkers of inflammation Interleukin-8
Interleukin-8 is a biomarker of inflammation
Measured: Study Day 28
Biomarkers of inflammation Tumor Necrosis Factor alpha
Tumor Necrosis Factor alpha is a biomarker of inflammation
Measured: Study Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start14 Jan 2022
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, exploratory clinical study to assess the patient safety and effect of oral apabetalone for up to 4 weeks in hospitalized subjects with Covid-19 infection. Subjects at each center will be randomized into 2 cohorts to receive SOC plus apabetalone or SOC alone.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resverlogix Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894266
- Sponsor's protocol ID
- RVX222-CS-023
- Status last verified
- Nov 2023
- First submitted
- 5 May 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Safety and Effect on Clinical Course and Key Biomarkers of Oral Apabetalone in Hospitalized Subjects With Covid-19 Infection in Addition to Standard of Care (SOC)
- ClinicalTrials.gov ID
- NCT04894266
- Acronym / sponsor ID
- RVX222-CS-023
- Conditions
- COVID-19 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Resverlogix CorpIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection
Detailed description
Primary Objective:
The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection
Secondary Objectives:
To evaluate the effect of apabetalone on biomarkers of inflammation (interleukin [IL]-6, IL-8, tumor necrosis factor [TNF]-α and C-reactive protein [CRP]) To evaluate the effect of apabetalone on key virus-related biomarkers including ACE2, serine protease inhibitor Clade A Member 8 (SERPINA8), angiotension (Ang) II and Ang (1-7) and others within the renin-angiotensin system (RAS) To evaluate the effect of apabetalone on clinical laboratory parameters including white blood cell (WBC) count, platelet count, D-Dimer, ferritin and clotting time in hospitalized subjects with Covid-19 infection To evaluate the effect of apabetalone cardiac and renal biomarkers including N-terminal pro B-type natriuretic peptide (NT-proBNP), troponin and Cystatin C To evaluate changes in viral levels measured via oropharyngeal or nasopharyngeal swabs To evaluate the effect of apabetalone on rate of admission to ICU, need for mechanical ventilation/ECMO, and death To evaluate the safety of apabetalone in hospitalized subjects with Covid-19 Infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, exploratory clinical study to assess the patient safety and effect of oral apabetalone for up to 4 weeks in hospitalized subjects with Covid-19 infection. Subjects at each center will be randomized into 2 cohorts to receive SOC plus apabetalone or SOC alone.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of careAll subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital. |
| Standard of Care plus apabetalone | Experimental | Drug: Apabetalone, Other: Standard of careAll subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital. For the apabetalone cohort, treatment will be administered BID with meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provide informed consent before participation in the study.
- Aged ≥18 years
- Hospital admission with symptoms suggestive of COVID-19 infection
- Ten days or less since the onset of symptoms
- Virological confirmation of SARS-CoV2 infection by reverse transcriptase PCR (RT- PCR) according to Center for Disease Control and Prevention (CDC) guidelines within the previous 72 hours
Key exclusion criteria (15 listed)
- Subjects with SpO2 >94% on room air using pulse oximetry and without bilateral infiltrates on chest imaging
- Subjects requiring mechanical ventilation or extracorporeal membrane oxygenation
- Patients with Stage 5 CKD receiving renal replacement therapy with either hemodialysis or peritoneal dialysis, renal transplant or with eGFR <15 mL/min/1.73 m2.
- Patients with prior transplantations of organs or bone marrow.
- Patients with unstable cardiac condition including heart attack, stroke, uncontrolled atrial fibrillation or a major cardiac procedure within 3 months as assessed by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApabetaloneApabetalone 100mg BID | Drug | Standard of Care plus apabetalone |
| Standard of careStandard of Care | Other | Standard of Care, Standard of Care plus apabetalone |
Primary outcome
The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14
Time frame: Change in WHO Ordinal Scale for Clinical Improvement at Day 14
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
5 secondary outcomes
Change in WHO Ordinal Scale for Clinical Improvement at Day 28
Time frame: Study Day 28
Biomarkers of inflammation Interleukin-6
Time frame: Study Day 28
Total time of hospitalization
Time frame: through study completion, an average of 28 days
Biomarkers of inflammation Interleukin-8
Time frame: Study Day 28
Biomarkers of inflammation Tumor Necrosis Factor alpha
Time frame: Study Day 28
Results and safety
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Apabetalone in people with COVID-19 Infection, run by Resverlogix Corp at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14 (time frame: Change in WHO Ordinal Scale for Clinical Improvement at Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.