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 |
| Impairment | |
| Neurological | |
| Pacs | |
| Participants | |
| Post | |
| Safety | |
| Score | |
| Study | |
| Symptoms | |
| Vix001 |
Semantics
| 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 |