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

PHASE1UnknownINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

April 1, 2025

Study Completion Date

September 1, 2025

Conditions
Post-Acute COVID-19 SyndromeCognitive ImpairmentNeurological Complication
Interventions
DRUG

VIX001

"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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Neobiosis, LLC

INDUSTRY

NCT05947617 - Safety, Efficacy, and Dosing of VIX001 in Patients With Neurological Symptoms of Post Acute COVID-19 Syndrome (PACS). | Biotech Hunter | Biotech Hunter