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

NCT04905836 | Unknown Phase 2 FDA Drug

• 1 other identifier: MSC-COV-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• All-cause mortality rate at Day 60 and 90

  Baseline through Day 60 and Day 90

• Number of ventilator-free days through Day 28

  Baseline through Day 28

• Number of ICU days through Day 28

  Baseline through Day 28

• Change in clinical status

  Baseline to Day 28

• Change in oxygenation

  Baseline to Day 14 Day 28, and Day 60

Study Arms (2)

COVI-MSC

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

COVI-MSC BIOLOGICAL

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

COVI-MSC

Placebo DRUG

Excipient solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (6)

Teradan Clinical Trials LLC

Brandon, Florida, 33511, United States

RECRUITING

Sarasota Memorial Health Care System (SMH)

Sarasota, Florida, 34239, United States

RECRUITING

St Luke's Research

Boise, Idaho, 83702, United States

RECRUITING

St. Luke's Boise

Boise, Idaho, 83702, United States

RECRUITING

Ascension St. John

Tulsa, Oklahoma, 74104, United States

RECRUITING

PRX Research/Dallas Regional Medical Center

Mesquite, Texas, 75149, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Mike Royal, MD

CONTACT

(858) 203-4100; mroyal@sorrentotherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: May 28, 2021
• Study Start: November 16, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

US (6)