A Study of Apabetalone in Subjects With Long -COVID

ConditionPost-Acute COVID-19 Syndrome

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorResverlogix Corp

About this trial

This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide written (signed and dated) informed consent before participation in the study, and to comply with scheduled visits, treatment plan, and other study-related procedures to complete the study.

Male or female subjects who are ≥ 18 years of age at Screening.

Documented history of T2DM

History of taking diabetes medication

Disqualifiers

Subjects with chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2

New York Heart Association Class IV congestive heart failure

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; chronic liver diseases such as primary biliary cholangitis, untreated hemochromatosis, and primary sclerosing cholangitis

Alanine transaminase (ALT) or aspartate transaminase (AST) values > 1.5x the upper limit of normal (ULN)

Trial design

Design model

Single group

Treatments tested in this trial

Apabetalone
Drug
100-mg capsule, twice daily oral administration with meals

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: apabetaloneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

patient acceptable symptom state (PASS)

The PASS assessment will consist of a single question phrased verbally by the delegated administrator as " Taking into account all your symptoms in daily life and your functional impairment, do you consider that your current state is satisfactory?". The response options are "Yes" or "No".

Time frame

90 days

Secondary outcomes

Long COVID Symptom and Impact tools (LCST/LCIT)

These questionnaires will be presented to the subjects in paper format as a patient-reported instrument. Subjects indicate with a check mark which of the 53 symptoms they have experienced in the last 30 days. Symptoms are scored as the number checked by the subject (0-53) The disease's impact on their lives over the past 30 days is scored from the responses to 6 questions. Subjects will answer using a numeric scale ranging from 0 (no impact) to 10 (maximal impact)

Time frame

90 days

Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a (SF-7a)

The PROMIS F-7a SF consists of seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week (NIH, 2007).

Time frame

90 days

Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)

The BDI and TDI are Interviewer-administered ratings of severity of dyspnea

Time frame

90 days

Post-COVID-19 Functional Status (PCFS) Scale

The PCFS is an ordinal scale of 5 steps ranging from Grade 0 (No functional limitations) to Grade 4 (Severe functional limitations). This scale will be self-administered by the patient

Time frame

90 days

Other outcomes

Biomarkers of inflammation

Change in biomarkers of inflammation from baseline. Assessed biomarkers will include Interferon (IFN): IFN-a, IFN-b, IFN-g, Interleukins (IL): IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-7, IL-10, IL-10Rb, IL-12b, IL-13, IL-17, IL-18, IL-33, IP-10 and Tumor Necrosis Factor (TNF): TNF-a, TNF-b

Time frame

Days 1,14,30,60,90

biomarkers associated with Post-COVID-19 Condition and Chronic Fatigue Syndrome

Change in levels of Post-COVID-19 Condition and Chronic Fatigue Syndrome associated proteins. Assessed biomarkers will include: Immune system markers: CD4+, CD8+, CD27+, CD62L+, NKCD57+ and perforin+. Vascular biomarkers: Ang-2, D-dimer, Factor VIII:C, MMP-1, MMP-9, sICAM-1, sVCAM-1, VEGF, VWF:Ag, VWF:pp

Time frame

Days 1,14,30,60,90

blood transcriptome and plasma proteome and metabolomics

Change in RNA expression attributable to Post-COVID-19 Condition. Micro-RNA's assayed will include hsa-miR146a-5p, hsa-miR-126-3p and hsa-miR-223-3p. SARS-CoV-2-related host RNAs (ACE2/TMPRSS2 receptors, DPP4/FURIN proteases) and RNAs prototypical for memory B-cells and platelets will also be evaluated

Time frame

baseline in blood cell transcriptome at Day 1, Day 14 and change from baseline in plasma proteome at Days 1,14,30,60,90

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Resverlogix Corp

Lead sponsor

Source ClinicalTrials.gov

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