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ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Post-Acute and Chronic Post-COVID-19 Syndrome: A Phase I/II Clinical Trial

NCT05116761•Direct Biologics, LLC

View on ClinicalTrials.gov

Summary

This is a Phase I/II trial to evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EV), ExoFlo, as treatment for Post-Acute COVID-19 and Chronic Post-COVID-19 syndrome.

Detailed Description

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
•2. Stated willingness to comply with all study procedures and availability for the duration of the study
•3. Male or female aged 18-85.
•4. Discharged from recent hospitalization for severe COVID-19 disease requiring supplemental oxygen but not requiring mechanical ventilation or ECMO or dialysis.
•5. Must be between 4 to 20 weeks since onset of acute COVID-19 symptoms onset.
•6. No return to baseline health or hiatus between acute COVID-19 and onset of post-acute COVID-19 or chronic post-COVID-19 syndrome.
•7. Current SARS-CoV-2 RT PCR must be negative prior to enrollment.
•8. At least 2 or more persistent symptoms frequently reported for post-acute COVID-19 or chronic post-COVID-19 syndrome such as fatigue, cough, headache, body aches, fever, chills, loss of taste, loss of smell, diarrhea, congestion, dyspnea, sore throat, chest pain, abdominal pain, confusion, or vomiting must be moderate in severity based on modified CDC Symptoms Questionnaire (See Section 11.1 for severity scoring system).
•9. Medical Resource Council Dyspnea Score of \< 3 out of 5.
•10. Baseline EQ-5D-5L must be higher than 21211. (Of note: EQ-5D-5L has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is scored from 1 (full) to 5 (worst), such that a score of 11111 is reflective of full quality-of-life and a score of 55555 is reflective of worst quality-of-life.)
+3 more criteria

Exclusion Criteria

•1. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
•2. Active malignancy requiring treatment within the last five years.
•3. Major physical trauma in the last 3 months, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries.
•4. Patients with persistent symptoms due to any of the following chronic comorbidities such as active tuberculosis or cystic fibrosis, chronic respiratory disease including chronic obstructive pulmonary disease or pulmonary fibrosis requiring baseline home oxygen \> 5 L O2/min, history of unstable angina or a heart attack during the last 12 months, pulmonary hypertension, hepatic impairment, chronic kidney disease, uncontrolled diabetes, substance abuse, severe osteoarthritis, HIV, migraine disorder, fibromyalgia, dementia, connective tissue disorders, and endocrine disorders.
•5. Depression as screened by positive Patient Health Questionnaire (PHQ2) and confirmed as moderate or higher severity on PHQ9 (See Appendix 11.5). Of note, subjects found to have moderate or higher on PHQ-9 will be referred for appropriate outpatient psychiatric evaluation and intervention for their depression.
•6. Vital sign abnormalities: temperature ≥ 38 °C, temperature \< 35 °C; systolic blood pressure (SBP) \< 90 mmHg, SBP ≥ 170 mmHg; diastolic blood pressure (DBP) \< 50 mmHg, DBP ≥ 100 mmHg; heart rate (HR) \< 50 beats per minute (BPM), HR ≥ 120 BPM.
•7. Lab abnormalities: WBC ≥ 12,000 /μL, Creatinine ≥ 1.5 mg/dL, AST ≥ 100 IU/l, and/or ALT ≥ 100 IU/I
•8. Patients who require rolling walker or wheelchair or higher level of assistance for ambulation.

Key Dates

Start Date

November 1, 2024

Primary Completion Date

November 1, 2024

Completion Date

December 1, 2024

Last Updated

November 22, 2024

Conditions

Covid19Postviral SyndromeDyspnea

Interventions

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

BIOLOGICAL

Saline

OTHER

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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: November 22, 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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ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome

Inclusion Criteria

Exclusion Criteria

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