- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125562
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
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.
Study Overview
Study Type
Phase
- Phase 2
Expanded Access
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Subjects who received COVID-19 vaccination are eligible for the study if it is more than 28 days since the last dose of vaccination. COVID-19 vaccination is not necessary for inclusion.
All subjects will need be on < 5 L O2/min to be included or on no oxygen to be enrolled in this study.
If the candidate is either male or female of reproductive potential, he or she must agree to use of double barrier method of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The duration of required usage of double barrier method OR maintenance of abstinence must include the time from the beginning of the screening period until 90 days following the last dose of the study treatment.
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
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment
Are >65 years of age
Are >55 years of age AND have
Cardiovascular disease, OR
Hypertension, OR
Chronic obstructive pulmonary disease/other chronic respiratory disease.
Patients who received SARS-CoV-2 monoclonal antibody treatment will be excluded from the study.
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.
Lab abnormalities: WBC ≥ 12,000 /μL, Creatinine ≥ 1.5 mg/dL, AST ≥ 100 IU/l, and/or ALT ≥ 100 IU/I
Patients who received COVID-19 vaccination within last 28 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
100ml normal saline
|
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
|
Experimental: 10ml ExoFlo
10ml ExoFlo + 90ml normal saline
|
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
|
Experimental: 15ml ExoFlo
15ml ExoFlo + 85ml normal saline
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SARS-CoV-2 log viral load from baseline to Day=7
Time Frame: 61 days
|
Change in SARS-CoV-2 log viral load from baseline to Day=7
|
61 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in viral load area under the curve (AUC) from baseline to Day=29
Time Frame: 61 days
|
Change in viral load area under the curve (AUC) from baseline to Day=29
|
61 days
|
Proportion of patients showing symptom improvement or resolution Day=7, 11, 15
Time Frame: 61 days
|
Proportion of patients showing symptom improvement or resolution Day=7, 11, 15
|
61 days
|
- Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29
Time Frame: 61 Days
|
- Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29
|
61 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bill Arana, Direct Biologics, LLC
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DB-EF-EMOTECOVID-0006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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