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

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ClinicalTrials.gov Identifier: NCT04728698
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid19 ARDS Drug: COVI-MSC Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVI-MSC
Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
Drug: COVI-MSC
1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level

Placebo Comparator: Placebo
Excipient
Drug: Placebo
Equivalent volume of placebo will be administered




Primary Outcome Measures :
  1. Mortality at Day 28 [ Time Frame: Randomization through Day 28 ]
    All-cause mortality at Day 28


Secondary Outcome Measures :
  1. Mortality at Days 60 and 90 [ Time Frame: Randomization through Day 60 and Day 90 ]
    All-cause mortality at Days 60 and 90

  2. Number of ventilator-free days [ Time Frame: Randomization through Day 28 ]
    Number of ventilator-free days through Day 28

  3. Improvement in oxygenation [ Time Frame: Randomization to Day 2, Day 4, Day 6, Day 14, Day 28 ]
    Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2

  4. SOFA score at Day 28 [ Time Frame: Randomization to Day 28 ]
    SOFA score at Day 28 compared to Baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728698


Contacts
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Contact: Mike Royal, MD 858-203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Locations
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United States, California
Fresno Community Hospital
Fresno, California, United States, 93710
Contact: Rebekah Garcia, CCRP    559-499-6636    rgarcia@fresno.ucsf.edu   
Contact: Christine Mergillano, BS, CCRP    559-499-6639    cmergillano@fresno.ucsf.edu   
Principal Investigator: Eyad Almasri, MD         
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04728698    
Other Study ID Numbers: MSC-COV-201
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021

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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
Keywords provided by Sorrento Therapeutics, Inc.:
covid-19
ARDS