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

Phase 2

• Conditions: Covid19
• Interventions: Drug: Placebo; Biological: COVI-MSC

• Registration Number: NCT04905836
• Lead Sponsor: Sorrento Therapeutics, Inc.

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.

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 Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-05-28
• Study Start: 2021-11-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
COVI-MSC	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

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (safety)	Baseline through study completion at Day 90	Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of severe adverse events (safety)	Baseline through study completion at Day 90	Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of infusion-related adverse events (safety)	Baseline to Hour 4	Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours
All-cause mortality rate at Day 28	Baseline through Day 28	All-cause mortality rate at Day 28
Incidence of all adverse events (AEs) (safety)	Baseline through study completion at Day 90	Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)

Secondary Outcome Measures

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

Trial Locations

Locations (6)

St Luke's Research; 🇺🇸 Boise, Idaho, United States

St. Luke's Boise; 🇺🇸 Boise, Idaho, United States

Teradan Clinical Trials LLC; 🇺🇸 Brandon, Florida, United States

Sarasota Memorial Health Care System (SMH); 🇺🇸 Sarasota, Florida, United States

Ascension St. John; 🇺🇸 Tulsa, Oklahoma, United States

PRX Research/Dallas Regional Medical Center; 🇺🇸 Mesquite, Texas, United States