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Clinical Trial Details

Trial ID: L3398
Source ID: NCT06590324
Associated Drug: Apabetalone
Title: A Study of Apabetalone in Subjects with Long -COVID
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Post-Acute COVID-19 Syndrome
Interventions: DRUG: Apabetalone
Outcome Measures: Primary: 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"., 90 days | Secondary: 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), 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)., 90 days|Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI), The BDI and TDI are Interviewer-administered ratings of severity of dyspnea, 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, 90 days|DePaul Symptom Questionnaire - Post-Exertional Malaise Short Form (DSQ-PEM), Post-exertional malaise (PEM) is a key symptom of chronic fatigue syndrome (CFS). Currently, five PEM-items from the DePaul Symptom Questionnaire (DSQ) will be used in this study to measure this symptom for patients with Post Covid Condition, 90 days | Other: 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, 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, 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, baseline in blood cell transcriptome at Day 1, Day 14 and change from baseline in plasma proteome at Days 1,14,30,60,90
Sponsor/Collaborators: Sponsor: Resverlogix Corp
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-30
Completion Date: 2025-11-30
Results First Posted:
Last Update Posted: 2024-09-19
Locations: The Speciality Hospital, Amman, Jordan|MNGHA- King Abdulaziz Hospital, Al Mubarraz, Saudi Arabia|Al Kuwait Hospital, Dubai, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT06590324