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Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19 | Clinical Trials | Clareo Health

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

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19: A Phase II Clinical Trial

NCT05125562•Direct Biologics, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligibility for study enrollment includes meeting all the following criteria:
•Provision of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
•Stated willingness to comply with all study procedures and availability for the duration of the study.
•Male or female aged 18-85.
•COVID-19 positive as defined by positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 determination \< 3 days prior to Day of Randomization.
•Must have mild or moderate COVID-19 as consistent with NIH definition:
•Mild COVID-19: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
•Moderate COVID-19: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air at sea level.
•Duration of illness from acute COVID-19 symptom onset must be 10 days or less.
•Only subjects who are not at high risk for progression to severe COVID-19 will be included in the study. See Exclusion Criterion #6.
+3 more criteria

Exclusion Criteria

•Exclusion from study enrollment includes meeting one or more of the following criteria:
•Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
•SpO2 \< 94% on ambient air.
•Active malignancy requiring treatment within the last five years.
•Major surgery or physical trauma in the last 3 months, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries.
•All subjects with any comorbidities that may be associated with risk of progression to severe COVID-19 including but not limited to renal dysfunction, hepatic disease, substance abuse, fibromyalgia, heart failure, uncontrolled arrhythmias, any level of dementia, depression, connective tissue diseases, major neuromuscular deficits, and endocrine disorders.
•Subjects found to be at high risk for progression to severe COVID-19 will be excluded from the study. These subjects will be referred to outpatient internal medicine clinic for SARS-CoV-2 monoclonal antibody treatment. As defined by the CDC and NIH, high risk for progression to severe COVID-19 is defined by meeting at least one of the following criteria:
•Body mass index (BMI) \>35
•Have chronic kidney disease
•Have diabetes
+11 more criteria

Key Dates

Start Date

December 7, 2022

Primary Completion Date

March 7, 2023

Completion Date

March 7, 2023

Last Updated

February 13, 2024

Conditions

COVID-19

Interventions

ExoFlo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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