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

Publication date: Jul 17, 2023

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.

Concepts Keywords
Kidney Acute
Miami Cognitive
Nasa Covid
Neurogenerative Dose
Vaccination Efficacy


Type Source Name
disease MESH Post Acute COVID-19 Syndrome
disease VO dose
disease MESH cognitive impairment
disease IDO quality
disease VO age
disease MESH SARS-CoV-2 infection
pathway REACTOME SARS-CoV-2 Infection
disease MESH infection
disease VO effective
disease IDO symptom
disease IDO history
disease IDO acute infection
disease MESH orthostatic intolerance
disease IDO blood
disease MESH Chronic kidney disease
disease MESH heart failure
disease MESH Chronic obstructive pulmonary disease
disease MESH Hepatitis B
pathway KEGG Hepatitis B
disease MESH Hepatitis C
pathway KEGG Hepatitis C
disease MESH stroke
disease MESH dementia
disease VO LACK
drug DRUGBANK Oxygen
drug DRUGBANK Ethanol
disease MESH substance abuse
disease VO time
disease MESH psychiatric illness
disease MESH Hyperthyroidism
disease MESH Hypothyroidism
disease MESH Thyroid disease
disease VO vaccination

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