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Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
Brazil
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
  • Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
  • 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
  • A previous stem cell infusion unrelated to this trial
  • Certain medical conditions that pose a safety risk to the subject
  • Pregnant or breast feeding or planning to during the study
  • Suspected uncontrolled active bacterial, fungal, viral, or other infection
  • History of splenectomy, lung transplant, or lung lobectomy
  • Concurrent participation in another clinical trial involving therapeutic interventions
  • 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) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing

Sites / Locations

  • Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
  • Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
  • Saraiva & Berlinger Ltda. - EPP (IPECC)
  • CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
  • Impar Serviços Hospitalares S/A (Hospital Nove de Julho)

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

Secondary Outcome Measures

All-cause mortality rate at Day 60 and Day 90
All-cause mortality rate at Day 60 and Day 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 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome)
Change in oxygenation
Change in oxygenation as assessed using PaO2:FiO2 ratio

Full Information

First Posted
May 21, 2021
Last Updated
January 5, 2023
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04903327
Brief Title
Study of Intravenous COVI-MSC for Treatment of 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
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to considerably slow enrollment, unable to reach enrollment targets
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
November 23, 2022 (Actual)

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 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.
Detailed Description
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4. Acceptable standard of care treatments for COVID-19 include all approved or emergency use authorized treatments for COVID-19, even if used off-label.

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
43 (Actual)

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
Secondary Outcome Measure Information:
Title
All-cause mortality rate at Day 60 and Day 90
Description
All-cause mortality rate at Day 60 and Day 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 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome)
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 2, Day 4, Day 6, Day 14 and Day 28

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 Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300 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 A previous stem cell infusion unrelated to this trial Certain medical conditions that pose a safety risk to the subject Pregnant or breast feeding or planning to during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection History of splenectomy, lung transplant, or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions 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) expect 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, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
City
Salvador
State/Province
BA
Country
Brazil
Facility Name
Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
City
Salvador
State/Province
BA
Country
Brazil
Facility Name
Saraiva & Berlinger Ltda. - EPP (IPECC)
City
Campinas
State/Province
SP
Country
Brazil
Facility Name
CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
City
Jaú
State/Province
SP
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
City
São Bernardo Do Campo
State/Province
SP
Country
Brazil
Facility Name
Impar Serviços Hospitalares S/A (Hospital Nove de Julho)
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

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