Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced 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, 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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19; ARDS
• Intervention / Treatment: Drug: COVI-MSC; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93710
      • Fresno Community Hospital

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at Day 28	All-cause mortality at Day 28	Randomization through Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at Days 60 and 90	All-cause mortality at Days 60 and 90	Randomization through Day 60 and Day 90
Number of ventilator-free days	Number of ventilator-free days through Day 28	Randomization 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	Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
SOFA score at Day 28	SOFA score at Day 28 compared to Baseline	Randomization to Day 28

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ARDS; 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-201

Drug and device information, study documents

• 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