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

Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: COVI-MSC; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mike Royal, MD; Phone Number: 4146 (858) 203-4100; Email: mroyal@sorrentotherapeutics.com

Study Locations

• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Teradan Clinical trials LLC
      • Contact: Daniel Lorch, MD; Phone Number: 813-603-4509; Email: STUDIES@TERADANCLINICALTRIALS.COM
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Health Care System (SMH)
      • Contact: Kirk Voelker, MD; Phone Number: 941-917-2225
  • Idaho
    • Boise, Idaho, United States, 83702
      • Recruiting
      • St Luke's Research
      • Contact: Lejla Godusevic
    • Boise, Idaho, United States, 83702
      • Recruiting
      • St. Luke's Boise
      • Contact: Karen Miller, MD; Phone Number: 208-381-7092
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Recruiting
      • Ascension St. John
      • Contact: Stacie Merritt, MSN, RN-BC; Phone Number: 918-744-3426
      • Principal Investigator: Jill Wenger, MD
  • Texas
    • Mesquite, Texas, United States, 75149
      • Recruiting
      • PRX Research/Dallas Regional Medical Center
      • Contact: Muhammad Saeed, MD; Phone Number: 214-320-7000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVI-MSC; 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	Biological: COVI-MSC; COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Placebo Comparator: Placebo; Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4	Drug: Placebo; Excipient solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality rate at Day 28	All-cause mortality rate at Day 28	Baseline through 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)	Baseline through study completion at Day 90
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	Baseline through study completion at Day 90
Incidence of severe adverse events (safety)	Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria	Baseline through study completion at Day 90
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	Baseline to Hour 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ventilator-free days through Day 28	Number of ventilator-free days through Day 28	Baseline through Day 28
All-cause mortality rate at Day 60 and 90	All-cause mortality rate at Day 60 and 90	Baseline through Day 60 and Day 90
Number of ICU days through Day 28	Number of ICU days through day 28	Baseline 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	Baseline to Day 28
Change in oxygenation	Change in oxygenation as assessed using PaO2:FiO2 ratio	Baseline to Day 14 Day 28, and Day 60

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: covid-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MSC-COV-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No