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

NCT05947617 | Unknown Phase 1 FDA Drug

• 2 other identifiers: IND_28592VIX001-PACS-01
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-Acute COVID-19 Syndrome; Cognitive Impairment; Neurological Complication

Keywords

Post-Acute COVID-19 Syndrome (PACS); Cognitive Impairment; Amniotic Fluid Product; VIX001; Neurological Symptoms; Phase 1 Trial; Dose-Escalation Study; Safety; Tolerability; Preliminary Efficacy; Dose Effect; Intravenous Injection; SARS-CoV-2 Infection; Montreal Cognitive Assessment (MoCA)

Outcome Measures

Primary Outcomes (9)

• Change from Baseline Six Minute Walk Test (6MWT) with oximetry.

  Physiologic assessments

  Day 0, 7, 30, 90, 180

• Change from Baseline Transthoracic Echocardiogram in 3 Dimensions (3-D TTE).

  Physiologic assessments

  Day 30, 90, 180

• Change from Baseline Pulmonary Function Test (PFT) with bronchodilation if abnormal.

  Physiologic assessments

  Day 30, 90, 180

• Change from Baseline Sleep time and depth parameters derived from wearable device (Biostrap).

  Physiologic assessments

  Day 180

• Change from Baseline Heart Rate Variability (HRV) during sleep, derived from wearable device (Biostrap).

  Physiologic assessments

  Day 180

• Change from Baseline UPSIT testers.

  Physiologic assessments

  Day 30, 90, 180

• Change from Baseline Montreal Cognitive Assessment (MoCA).

  Physiologic assessments

  Day 0, 7, 30, 90, 180

• Change from Baseline NASA 10-Minute Lean Test.

  Physiologic assessments

  Day 7, 30, 90, 180

• Change from Baseline CNS Vital Signs test battery.

  Physiologic assessments

  Day 7, 30, 90, 180

Secondary Outcomes (4)

• PROMIS

  Day 0, 7, 30, 90, 180

• mMRC Scale.

  Day 0, 7, 30, 90, 180

• General Anxiety Disorder (GAD-7).

  Day 0, 7, 30, 90, 180

• Personal Health Questionnaire Depression Scale (PHQ-8).

  Day 0, 7, 30, 90, 180

Study Arms (3)

Arm 1: Low Dose (1 ml) VIX001

EXPERIMENTAL

Participants in this arm will receive intravenous injections of VIX001 at a low dose of 1 ml. The intervention involves the administration of VIX001 diluted in clinical standard saline.

Drug: VIX001

Arm 2: Intermediate Dose (3 ml) VIX001

EXPERIMENTAL

Participants in this arm will receive intravenous injections of VIX001 at an intermediate dose of 3 ml. The intervention entails the administration of VIX001 diluted in clinical standard saline.

Drug: VIX001

Arm 3: High Dose (10 ml) VIX001

EXPERIMENTAL

Participants in this arm will receive intravenous injections of VIX001 at a high dose of 10 ml. The intervention involves the administration of VIX001 diluted in clinical standard saline.

Drug: VIX001

Interventions

VIX001 DRUG

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.

Also known as: Purified Amniotic Fluid

Arm 1: Low Dose (1 ml) VIX001; Arm 2: Intermediate Dose (3 ml) VIX001; Arm 3: High Dose (10 ml) VIX001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen, which did not require intubation or mechanical or non-invasive ventilation to address the SARS-CoV-2 infection. Only those who had COVID-19 and who were not hospitalized for their infection and are eligible for this study.
• Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test).
• Has had at least moderate or severe post-COVID-19 symptoms for at least 3 months which have resulted in reduced functioning compared to pre-COVID-19 status, and a working diagnosis of post-acute COVID-19 syndrome (PACS).
• Ability to comply with the requirements of the study, including anticipated ability to attend all scheduled visits.
• Ability to understand and provide written informed consent.
• All participants of reproductive age/capacity will be required to use adequate contraception, defined as two forms of highly effective contraceptives, with any partners during the study period and for at least three months beyond the study period for safety.
• The primary presenting symptom impeding daily function is neurological.
• Objective assessment of orthostatic intolerance as determined by a change of 30 in pulse or blood pressure on NASA 10-Minute Lean Test in patients who had no prior history of autonomic dysfunction;
• Symptomatic depression (defined as a score of \<10 on the PHQ-8 patient reported outcome questionnaire) at the time of screening that must have been controlled on a stable therapy (pharmacological or in the care of a therapist) for three months prior to planned infusion, are under the active care of a mental health provider during the study period, and was not present prior to contracting COVID-19.;
• Anxiety on GAD-7 with a score of ≥10 and ≤ 15 that was not present prior to contracting COVID-19; and
• Sleep disturbance on PROMIS-SD with a score of ≥30 that was not present prior to contracting COVID-19.

You may not qualify if:

• Significant concurrent medical conditions (verified by medical records as needed), including the following:
• Poorly controlled diabetes mellitus, defined as HbA1C\>8.5.
• Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR \< 60mL/min/1.73m2.
• Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit.
• Blood pressure \> 180/110 mm/Hg during screening visit.
• Chronic obstructive pulmonary disease (COPD).
• Participants with HIV, Hepatitis B and Hepatitis C.
• Participants with a prior history of stroke, neurogenerative disease, dementia, or developmental delay.
• Participants with \< 18 on MoCA will be excluded, as well as any who have an active power of attorney or other legal basis to be deemed to lack capacity.
• Participants who require ongoing oxygen ventilation.
• Other clinically significant, ongoing illness or medical condition, that in the opinion of the investigator constitutes a safety risk for participation in the study or that could interfere with achieving the study objectives, conduct or evaluation, including a history of thromboembolic events.
• Participants who are pregnant or lactating.
• Active alcohol or substance abuse or any other reason that makes it unlikely that the participant will comply with study procedures.
• Infusion of any other investigational agents within 6 months of randomization.
• All subjects with PHQ-8 score \>10 at the time of enrollment screening will be excluded from the study.

Sponsors & Collaborators

• Neobiosis, LLC: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Cognitive Dysfunction; Neurologic Manifestations; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Signs and Symptoms

Study Officials

• Roger Alvarez, DO, MPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger Alvarez, DO, MPH

CONTACT

305-243-7888; rogeralvarez@med.miami.edu

Mercedes Kweh, PhD

CONTACT

305-502-5790; mercedes.kweh@neobiosis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study follows a dose-escalation design where participants are enrolled in sequential cohorts receiving escalating doses of VIX001 (1 ml, 3 ml, or 10 ml). This suggests a sequential approach in terms of dose administration within the study.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 17, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share