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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

Primary Purpose

Covid19

Status
Recruiting
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

Eligibility Criteria

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

Inclusion Criteria:

  • Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record)
  • Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
  • Requires oxygen supplementation at Screening
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
  • Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O
  • A previous stem cell infusion unrelated to this trial
  • 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
  • Has an existing "Do Not Intubate" order
  • Has undergone 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 (eg, obstructive sleep apnea)
  • Has 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

Sites / Locations

  • Teradan Clinical Trials LLCRecruiting
  • Sarasota Memorial Health Care System (SMH)Recruiting
  • St Luke's ResearchRecruiting
  • St. Luke's BoiseRecruiting
  • Ascension St. JohnRecruiting
  • PRX Research/Dallas Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVI-MSC

Placebo

Arm Description

Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4

Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

Outcomes

Primary Outcome Measures

All-cause mortality rate at Day 28
All-cause mortality rate at Day 28
Incidence of all adverse events (AEs) (safety)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Incidence of treatment-emergent adverse events (safety)
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of severe adverse events (safety)
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of infusion-related adverse events (safety)
Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours

Secondary Outcome Measures

All-cause mortality rate at Day 60 and 90
All-cause mortality rate at Day 60 and 90
Number of ventilator-free days through Day 28
Number of ventilator-free days through Day 28
Number of ICU days through Day 28
Number of ICU days through day 28
Change in clinical status
Change in clinical status as assessed using the WHO Clinical Progression Scale (0-10 scale, where lower score means a better outcome) at Day 28
Change in oxygenation
Change in oxygenation as assessed using PaO2:FiO2 ratio

Full Information

First Posted
May 27, 2021
Last Updated
April 7, 2022
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04905836
Brief Title
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 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
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (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

5. Study Description

Brief Summary
This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.
Detailed Description
This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory stress (ARD) / acute respiratory distress syndrome (ARDS). Subjects will be randomized 1:1 COVI-MSC to placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVI-MSC
Arm Type
Experimental
Arm Description
Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
Intervention Type
Biological
Intervention Name(s)
COVI-MSC
Intervention Description
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Excipient solution
Primary Outcome Measure Information:
Title
All-cause mortality rate at Day 28
Description
All-cause mortality rate at Day 28
Time Frame
Baseline through Day 28
Title
Incidence of all adverse events (AEs) (safety)
Description
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Time Frame
Baseline through study completion at Day 90
Title
Incidence of treatment-emergent adverse events (safety)
Description
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Time Frame
Baseline through study completion at Day 90
Title
Incidence of severe adverse events (safety)
Description
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Time Frame
Baseline through study completion at Day 90
Title
Incidence of infusion-related adverse events (safety)
Description
Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours
Time Frame
Baseline to Hour 4
Secondary Outcome Measure Information:
Title
All-cause mortality rate at Day 60 and 90
Description
All-cause mortality rate at Day 60 and 90
Time Frame
Baseline through Day 60 and Day 90
Title
Number of ventilator-free days through Day 28
Description
Number of ventilator-free days through Day 28
Time Frame
Baseline through Day 28
Title
Number of ICU days through Day 28
Description
Number of ICU days through day 28
Time Frame
Baseline through Day 28
Title
Change in clinical status
Description
Change in clinical status as assessed using the WHO Clinical Progression Scale (0-10 scale, where lower score means a better outcome) at Day 28
Time Frame
Baseline to Day 28
Title
Change in oxygenation
Description
Change in oxygenation as assessed using PaO2:FiO2 ratio
Time Frame
Baseline to Day 14 Day 28, and Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record) Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Requires oxygen supplementation at Screening Willing to follow contraception guidelines Exclusion Criteria: Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O A previous stem cell infusion unrelated to this trial 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 Has an existing "Do Not Intubate" order Has undergone 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 (eg, obstructive sleep apnea) Has 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Royal, MD
Phone
(858) 203-4100
Ext
4146
Email
mroyal@sorrentotherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teradan Clinical Trials LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Lorch, MD
Phone
813-603-4509
Email
STUDIES@TERADANCLINICALTRIALS.COM
Facility Name
Sarasota Memorial Health Care System (SMH)
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirk Voelker, MD
Phone
941-917-2225
Facility Name
St Luke's Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lejla Godusevic
Facility Name
St. Luke's Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Miller, MD
Phone
208-381-7092
Facility Name
Ascension St. John
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacie Merritt, MSN, RN-BC
Phone
918-744-3426
First Name & Middle Initial & Last Name & Degree
Jill Wenger, MD
Facility Name
PRX Research/Dallas Regional Medical Center
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Saeed, MD
Phone
214-320-7000

12. IPD Sharing Statement

Learn more about this trial

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

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