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Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

Primary Purpose

Covid19, ARDS, Hypoxia

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

ExoFlo

About this trial

This is an expanded access trial for Covid19 focused on measuring COVID-19, ARDS, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

Provision of informed consent by self or proxy.
Stated willingness to comply with study protocol.
Male or female of any age≥ 18 years of age
May be pregnantunless the patient has one or more conditions listed under Exclusion Criteria #4.
PositiveReverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2.
Moderate to severe ARDS as defined by timing within 1 week of known clinical insult or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions or lung collapse, and respiratory failure not fully explained by cardiac failure or fluid overload, and PaO2/FiO2£200 mmHg.
Acute presentation of hypoxic respiratory failurerequiring noninvasive oxygen support OR mechanical ventilation (MV).
Agreementto use highly effective birth control contraceptionif of reproductive age and potential.

Exclusion Criteria:

Active malignancy requiring treatment within the last five years.
Eligibility for enrollment in Protocol DB-EF-PhaseII-001.
Patients who are not full code.
Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome during pregnancy.
New York Heart Association (NYHA)Functional Class III (symptoms present during ordinary activities) or IV Heart Failure (symptoms present at rest)or listed for heart transplant.
Chronic Kidney Disease (CKD) Stage IV (GFR 15-29 mL/min/1.73m2)and Stage V (GFR <15mL/min/1.73m2)or listed forkidneytransplant.
Hepatic Impairment with Model for End-Stage Liver Disease (MELD) score ≥ 30or listed for liver transplant.
Use of extracorporeal membrane oxygenation (ECMO) during the current hospitalization.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04657458

First Posted

December 7, 2020

Last Updated

April 17, 2023

Sponsor

Direct Biologics, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04657458

Brief Title

Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

Official Title

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS

Study Type

Expanded Access

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Direct Biologics, LLC

4. Oversight

5. Study Description

Brief Summary

ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute respiratory distress syndrome (ARDS). This expanded access protocol is an open label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase III randomized controlled trial (RCT) because they Do not meet phase III eligibility criteria at current phase III sites. Do meet phase III eligibility criteria but cannot access phase III sites. Do not meet phase III eligibility criteria & cannot access phase III sites.

Detailed Description

Objectives: First, to provide Investigational Medicinal Product (IMP) to patients with COVID-19 associated moderate to severe ARDS who do not qualify for Protocol DB-EF-PHASEIII-0001. Secondarily, to collect safety and efficacy data. Endpoints: Primary Endpoint: 1) 60-day All-Cause Mortality Secondary Endpoints: Incidence of serious adverse events (SAEs). Ventilator-free days (VFDs). Time to discharge. Exploratory Endpoints: Acute phase reactants: C-reactive protein (CRP), D-dimer, and Ferritin change from Baseline on Days 3, 5, 7, 10, 15, and 29 for subjects who are still hospitalized. Sequential Organ Failure Assessment (SOFA) Score change from Baseline on Days 15, and 29 for subjects who are still hospitalized. Improvement in partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ratio from pre-infusion baseline (Day 0) to Day 7. PaO2 may be calculated from arterial blood gas (ABG) or imputed from the SpO2 daily. Number of subjects: ≤200 Phase: Phase II /Expanded Access Protocol for Intermediate Population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, ARDS, Hypoxia, Cytokine Storm

Keywords

COVID-19, ARDS, SARS-CoV-2

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

ExoFlo

Intervention Description

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: Provision of informed consent by self or proxy. Stated willingness to comply with study protocol. Male or female of any age ≥ 18 years of age May be pregnant unless the patient has one or more conditions listed under Exclusion Criteria #3. Positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2. Moderate to severe ARDS as defined by timing within ten days of known clinical insult or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions or lung collapse, and respiratory failure not fully explained by cardiac failure or fluid overload, minimum 5 cm H2O PEEP on mechanical ventilation, and PaO2/FiO2 ≤ 200 mmHg (if using an estimated P/F ratio, a S/F ≤ 235 is accepted). Acute presentation of hypoxic respiratory failure requiring noninvasive oxygen support OR mechanical ventilation (MV). Exclusion Criteria: Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers. Patients who are not full code. Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, or low platelet count (HELLP) syndrome during pregnancy. New York Heart Association (NYHA) Functional Class III (symptoms present during ordinary activities) or IV Heart Failure (symptoms present at rest) or listed for heart transplant. Chronic Kidney Disease (CKD) Stage IV (GFR 15-29 mL/min/1.73m2) and Stage V (GFR < 15 mL/min/1.73m2) or listed for kidney transplant. Hepatic Impairment with Model for End-Stage Liver Disease (MELD) score ≥ 30 or listed for liver transplant.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Lightner, MD

Phone

512-354-7124

alightner@directbiologics.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stephanie Cahill

scahill@directbiologics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Lightner, MD

Organizational Affiliation

Direct Biologics, LLC

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

https://directbiologics.com/

Description

Direct Biologics, LLC

Learn more about this trial

Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

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