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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905836
• Other study ID #: MSC-COV-202
• Status: Recruiting
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: Sorrento Therapeutics, Inc.
• Contact: Mike Royal, MD
• Phone: (858) 203-4100
• Email: mroyal[@]sorrentotherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Drug:
• Placebo
Excipient solution

Locations

Country	Name	City	State
United States	St Luke's Research	Boise	Idaho
United States	St. Luke's Boise	Boise	Idaho
United States	Teradan Clinical Trials LLC	Brandon	Florida
United States	PRX Research/Dallas Regional Medical Center	Mesquite	Texas
United States	Sarasota Memorial Health Care System (SMH)	Sarasota	Florida
United States	Ascension St. John	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate at Day 28	All-cause mortality rate at Day 28	Baseline through Day 28
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Number of ventilator-free days through Day 28	Number of ventilator-free days through Day 28	Baseline through Day 28
Secondary	Number of ICU days through Day 28	Number of ICU days through day 28	Baseline through Day 28
Secondary	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
Secondary	Change in oxygenation	Change in oxygenation as assessed using PaO2:FiO2 ratio	Baseline to Day 14 Day 28, and Day 60