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

NCT ID: NCT04728698

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-09-30

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.

Conditions

Covid19; ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

COVI-MSC

Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)

Group Type: EXPERIMENTAL

COVI-MSC

Intervention Type: DRUG

1 x 10\^6 MSCs/kg or 1.5 x 10\^6 MSCs/kg, depending on CRP level

Placebo

Excipient

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Equivalent volume of placebo will be administered

Interventions

COVI-MSC

1 x 10\^6 MSCs/kg or 1.5 x 10\^6 MSCs/kg, depending on CRP level

Intervention Type: DRUG

Placebo

Equivalent volume of placebo will be administered

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Royal, MD

Role: STUDY_DIRECTOR

Sorrento Therapeutics

Locations

Fresno Community Hospital

Fresno, California, United States

Countries

United States

Other Identifiers

MSC-COV-201

Identifier Type: -

Identifier Source: org_study_id