Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

Sponsor

Sorrento Therapeutics, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04728698

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 ARDS	Drug: COVI-MSC Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mortality at Day 28 [Randomization through Day 28]
All-cause mortality at Day 28

Secondary Outcome Measures

Mortality at Days 60 and 90 [Randomization through Day 60 and Day 90]
All-cause mortality at Days 60 and 90
Number of ventilator-free days [Randomization through Day 28]
Number of ventilator-free days through Day 28
Improvement in oxygenation [Randomization to Day 2, Day 4, Day 6, Day 14, Day 28]
Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2
SOFA score at Day 28 [Randomization to Day 28]
SOFA score at Day 28 compared to Baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fresno Community Hospital	Fresno	California	United States	93710

Sponsors and Collaborators

Sorrento Therapeutics, Inc.

Investigators

Study Director: Mike Royal, MD, Sorrento Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sorrento Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04728698

Other Study ID Numbers:

MSC-COV-201

First Posted:

Jan 28, 2021

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sorrento Therapeutics, Inc.

covid-19

ARDS

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 16, 2021