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

NCT05125562 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: DB-EF-EMOTECOVID-0006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

COVID-19

Keywords

ExoFlo; COVID-19; Extracellular Vesicle; Mild

Outcome Measures

Primary Outcomes (1)

• 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

  61 days

Secondary Outcomes (3)

• 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

  61 days

• - Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29

  61 Days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

100ml normal saline

Drug: ExoFlo

10ml ExoFlo

EXPERIMENTAL

10ml ExoFlo + 90ml normal saline

Drug: ExoFlo

15ml ExoFlo

EXPERIMENTAL

15ml ExoFlo + 85ml normal saline

Drug: ExoFlo

Interventions

ExoFlo DRUG

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

10ml ExoFlo; 15ml ExoFlo; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Direct Biologics, LLC: lead

MeSH Terms

Conditions

COVID-19; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bill Arana

  Direct Biologics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 18, 2021
• Study Start: December 7, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share