Safety, Efficacy, and Dosing of VIX001 in Patients With Neurological Symptoms of Post Acute COVID-19 Syndrome (PACS).

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.