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Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19

NCT05125562 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-13

No results posted yet for this study

Summary

Early Mild Outpatient infusion Therapy with ExoFloTM for COVID-19 (EMOTE COVID-19)

To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for mild-moderate COVID-19.

Conditions

Interventions

DRUG

ExoFlo

Patients will be randomized to one of three infusions: (1) Normal Saline 100 mL, (2) Normal saline 90 mL and ExoFlo 10 mL, which is 7x1011 EVs, and (3) Normal saline 85 mL and ExoFlo 15 mL, which is 10.5x1011 EVs. The study intervention will only be dosed on day=1

Sponsors & Collaborators

  • Direct Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Bill Arana · Direct Biologics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2023-03-07
Completion
2023-03-07
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125562 on ClinicalTrials.gov