COVID-19Phase 2NCT05125562
Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19
A Phase 2 study testing ExoFlo in people with COVID-19, run by Direct Biologics, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- ExoFlo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2022to 7 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- ExoFlo
- Keywords
- ExoFlo, COVID-19, Extracellular Vesicle, Mild
- Medical subject headings
- COVID-19, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoFloDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100ml normal saline Receives: Drug: ExoFlo |
| 10ml ExoFlo | Experimental | 10ml ExoFlo + 90ml normal saline Receives: Drug: ExoFlo |
| 15ml ExoFlo | Experimental | 15ml ExoFlo + 85ml normal saline Receives: Drug: ExoFlo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SARS-CoV-2 log viral load from baseline to Day=7
Change in SARS-CoV-2 log viral load from baseline to Day=7
Measured: 61 days
Secondary outcomes (3)
Change in viral load area under the curve (AUC) from baseline to Day=29
Change in viral load area under the curve (AUC) from baseline to Day=29
Measured: 61 days
Proportion of patients showing symptom improvement or resolution Day=7, 11, 15
Proportion of patients showing symptom improvement or resolution Day=7, 11, 15
Measured: 61 days
- Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29
- Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29
Measured: 61 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start7 Dec 2022 (estimated)
- Primary completion7 Mar 2023 (estimated)
- Study completion7 Mar 2023 (estimated)
Why it stopped: Sponsor has withdrawn/closed the IND with the FDA. A letter dated 21NOV2022 was submitted to the FDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direct Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Arana, Study director, Direct Biologics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125562
- Sponsor's protocol ID
- DB-EF-EMOTECOVID-0006
- Status last verified
- Feb 2024
- First submitted
- 11 Nov 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05125562
- Acronym / sponsor ID
- DB-EF-EMOTECOVID-0006
- Conditions
- COVID-19
- Keywords
- ExoFlo, COVID-19, Extracellular Vesicle, Mild
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has withdrawn/closed the IND with the FDA. A letter dated 21NOV2022 was submitted to the FDA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Direct Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2022 (estimated)
- Primary completion
- 7 Mar 2023 (estimated)
- Study completion
- 7 Mar 2023 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: ExoFlo100ml normal saline |
| 10ml ExoFlo | Experimental | Drug: ExoFlo10ml ExoFlo + 90ml normal saline |
| 15ml ExoFlo | Experimental | Drug: ExoFlo15ml ExoFlo + 85ml normal saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoFloPatients 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 | Drug | 10ml ExoFlo, 15ml ExoFlo, Placebo |
Primary outcome
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
3 secondary outcomes
Change in viral load area under the curve (AUC) from baseline to Day=29
Time frame: 61 days
Proportion of patients showing symptom improvement or resolution Day=7, 11, 15
Time frame: 61 days
- Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29
Time frame: 61 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Arana study director
Direct Biologics, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ExoFlo in people with COVID-19, run by Direct Biologics, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SARS-CoV-2 log viral load from baseline to Day=7 (time frame: 61 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.