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

NCT04728698 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MSC-COV-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

covid-19; ARDS

Outcome Measures

Primary Outcomes (1)

• Mortality at Day 28

  All-cause mortality at Day 28

  Randomization through Day 28

Secondary Outcomes (4)

• Mortality at Days 60 and 90

  Randomization through Day 60 and Day 90

• Number of ventilator-free days

  Randomization through Day 28

• Improvement in oxygenation

  Randomization to Day 2, Day 4, Day 6, Day 14, Day 28

• SOFA score at Day 28

  Randomization to Day 28

Study Arms (2)

COVI-MSC

EXPERIMENTAL

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

Drug: COVI-MSC

Placebo

PLACEBO COMPARATOR

Excipient

Drug: Placebo

Interventions

COVI-MSC DRUG

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

COVI-MSC

Placebo DRUG

Equivalent volume of placebo will be administered

Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• \. 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

Fresno Community Hospital

Fresno, California, 93710, United States

Location

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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)