The study, identified as VIX001-PACS-01, is a Phase 1, open-label, dose-escalation trial evaluating the safety, tolerability, preliminary efficacy, and dose effect of VIX001, an amniotic fluid product, in patients with Post-Acute COVID-19 Syndrome (PACS) and cognitive impairment. Conducted at the University of Miami Hospital and Clinics, the trial aims to enroll up to nine participants, or up to 18 using a 3+3 dose escalation design. Intravenous injections of VIX001 will be administered at three ascending doses (1 ml, 3 ml, or 10 ml), and participants will be assessed for safety, cognitive impairment, pain, activity, and quality of life at baseline and various timepoints. The primary objective is to evaluate the safety of VIX001, while secondary objectives include assessing its potential efficacy and patient-reported outcomes. The study duration is expected to last approximately 18 months, including enrollment, evaluation, and post-study observation periods. The findings will contribute to understanding VIX001's safety and efficacy in treating PACS-related cognitive impairment.
Study Title: A Phase 1, Open-label Dose-Escalation Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of VIX001 Amniotic Fluid Product in Patients with Post-Acute COVID-19 Syndrome (PACS) Associated with Neurological Symptoms of Cognitive Impairment Study Number: VIX001-PACS-01 Study Design: This is a Phase 1, open-label, dose-escalation trial aimed at evaluating the safety, tolerability, preliminary efficacy, and dose effect of VIX001, an amniotic fluid product, in patients with Post-Acute COVID-19 Syndrome (PACS) who are experiencing neurological symptoms of cognitive impairment. The study will follow a 3+3 dose escalation design, with up to nine participants enrolled initially, and a possibility of expanding to up to 18 participants if toxicities occur within the predefined dosing range. Study Objectives: The primary objective of the study is to assess the safety of VIX001 when administered intravenously to patients with PACS and cognitive impairment. The secondary objectives include evaluating the preliminary efficacy of VIX001 on cognitive impairment, pain, activity, and quality of life in these patients. Study Center: The study will be conducted at the University of Miami Hospital and Clinics. Study Duration: The anticipated duration of the study is approximately 18 months. This includes a six-month enrollment period, a six-month evaluation period for each participant, and a six-month post-study observation period. Participant Eligibility Criteria: To be eligible for the study, participants must have a prior laboratory-confirmed SARS-CoV-2 infection, a recent negative SARS-CoV-2 test, and have experienced moderate or severe post-COVID-19 symptoms for a minimum of three months. Participants should exhibit reduced physical functioning compared to their pre-COVID-19 status and present with neurological impairment, as indicated by a score of ≤ 24 on the Montreal Cognitive Assessment (MoCA). Investigational Product: VIX001 is an amniotic fluid product derived from qualified donors. It will be administered intravenously at three ascending doses: 1 ml, 3 ml, or 10 ml. VIX001 will be diluted in clinical standard saline for administration. Study Procedures: Participants will receive intravenous injections of VIX001 at the assigned dose level. Safety evaluations, including medical history, physical examinations, and selected laboratory tests, will be conducted at specified timepoints. Cognitive impairment, pain, activity, and quality of life will also be assessed using validated measures at baseline and at multiple timepoints during the study. Endpoints: The primary endpoint of the study is the safety of VIX001, which will be evaluated by monitoring treatment-emergent adverse events. The secondary endpoints include changes in cognitive impairment and various patient-reported outcomes related to PACS, such as pain, activity levels, and quality of life. Planned Participant Number: The study aims to enroll up to nine participants initially, or up to 18 participants if toxicities occur within the predefined dosing range. This Phase 1 clinical trial aims to assess the safety, tolerability, preliminary efficacy, and dose effect of VIX001, an amniotic fluid product, in patients with PACS and cognitive impairment. The findings will contribute to understanding the potential of VIX001 as a therapeutic intervention for patients with neurological symptoms associated with PACS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
This study utilizes a dose-escalation design with three arms or cohorts to evaluate the safety, tolerability, preliminary efficacy, and dose effect of VIX001, an amniotic fluid product, in patients with Post-Acute COVID-19 Syndrome (PACS) associated with neurological symptoms of cognitive impairment. In all arms, the intervention will be administered at baseline and participants will be assessed at specified timepoints for safety, cognitive impairment, pain, activity, and quality of life. The primary objective is to evaluate the safety of VIX001, while the secondary objectives include assessing its potential efficacy and patient-reported outcomes.
Change from Baseline Six Minute Walk Test (6MWT) with oximetry.
Physiologic assessments
Time frame: Day 0, 7, 30, 90, 180
Change from Baseline Transthoracic Echocardiogram in 3 Dimensions (3-D TTE).
Physiologic assessments
Time frame: Day 30, 90, 180
Change from Baseline Pulmonary Function Test (PFT) with bronchodilation if abnormal.
Physiologic assessments
Time frame: Day 30, 90, 180
Change from Baseline Sleep time and depth parameters derived from wearable device (Biostrap).
Physiologic assessments
Time frame: Day 180
Change from Baseline Heart Rate Variability (HRV) during sleep, derived from wearable device (Biostrap).
Physiologic assessments
Time frame: Day 180
Change from Baseline UPSIT testers.
Physiologic assessments
Time frame: Day 30, 90, 180
Change from Baseline Montreal Cognitive Assessment (MoCA).
Physiologic assessments
Time frame: Day 0, 7, 30, 90, 180
Change from Baseline NASA 10-Minute Lean Test.
Physiologic assessments
Time frame: Day 7, 30, 90, 180
Change from Baseline CNS Vital Signs test battery.
Physiologic assessments
Time frame: Day 7, 30, 90, 180
PROMIS
Patient-Reported outcomes 1. Sleep Disturbance 2. Fatigue 3. Physical Function 4. Pain Interference
Time frame: Day 0, 7, 30, 90, 180
mMRC Scale.
Patient-Reported outcomes
Time frame: Day 0, 7, 30, 90, 180
General Anxiety Disorder (GAD-7).
Patient-Reported outcomes
Time frame: Day 0, 7, 30, 90, 180
Personal Health Questionnaire Depression Scale (PHQ-8).
Patient-Reported outcomes
Time frame: Day 0, 7, 30, 90, 180
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