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Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

Primary Purpose

Covid19, ARDS

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COVI-MSC
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19, ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provides informed consent
  • Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
  • 3. Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas
  • Requires oxygen supplementation at screening
  • Is willing to follow contraception requirements

Exclusion Criteria:

  • Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
  • A previous MSC infusion unrelated to this trial

  • Have any of the following medical conditions:

    • Cardio-pulmonary resuscitation within 14 days of randomization
    • Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll
    • Myocardial infarction within the last 6 weeks
    • Congestive heart failure (NYHA Grade 3 or 4)
    • Pulmonary hypertension (WHO Class III/IV)
    • Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO)
    • Alanine aminotransferase (ALT) ≥ 5x upper limit of normal (ULN)
    • Relevant renal impairment (eGFR < 50 mL/min)
    • Any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study
  • Pregnant or breast feeding or planning for either during the study
  • Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
  • History of a splenectomy, lung transplant or lung lobectomy;
  • Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable).
  • Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days.
  • Do Not Intubate order;
  • Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing

Sites / Locations

  • Fresno Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVI-MSC

Placebo

Arm Description

Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)

Excipient

Outcomes

Primary Outcome Measures

Mortality at Day 28
All-cause mortality at Day 28

Secondary Outcome Measures

Mortality at Days 60 and 90
All-cause mortality at Days 60 and 90
Number of ventilator-free days
Number of ventilator-free days through Day 28
Improvement in oxygenation
Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2
SOFA score at Day 28
SOFA score at Day 28 compared to Baseline

Full Information

First Posted
January 26, 2021
Last Updated
September 14, 2021
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04728698
Brief Title
Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress
Official Title
Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Replaced by a different protocol.
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, ARDS
Keywords
covid-19, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVI-MSC
Arm Type
Experimental
Arm Description
Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Excipient
Intervention Type
Drug
Intervention Name(s)
COVI-MSC
Intervention Description
1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Equivalent volume of placebo will be administered
Primary Outcome Measure Information:
Title
Mortality at Day 28
Description
All-cause mortality at Day 28
Time Frame
Randomization through Day 28
Secondary Outcome Measure Information:
Title
Mortality at Days 60 and 90
Description
All-cause mortality at Days 60 and 90
Time Frame
Randomization through Day 60 and Day 90
Title
Number of ventilator-free days
Description
Number of ventilator-free days through Day 28
Time Frame
Randomization through Day 28
Title
Improvement in oxygenation
Description
Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2
Time Frame
Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
Title
SOFA score at Day 28
Description
SOFA score at Day 28 compared to Baseline
Time Frame
Randomization to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provides informed consent Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen 3. Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas Requires oxygen supplementation at screening Is willing to follow contraception requirements Exclusion Criteria: Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving A previous MSC infusion unrelated to this trial Have any of the following medical conditions: Cardio-pulmonary resuscitation within 14 days of randomization Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll Myocardial infarction within the last 6 weeks Congestive heart failure (NYHA Grade 3 or 4) Pulmonary hypertension (WHO Class III/IV) Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO) Alanine aminotransferase (ALT) ≥ 5x upper limit of normal (ULN) Relevant renal impairment (eGFR < 50 mL/min) Any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19) History of a splenectomy, lung transplant or lung lobectomy; Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable). Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days. Do Not Intubate order; Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Fresno Community Hospital
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

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