Recruiting
Phase 2

Adipose-Derived Stem Cells

Sponsor:

Sorrento Therapeutics, Inc.

Code:

NCT04905836

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COVI-MSC

Placebo

Study Details

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.

Conditions

Covid19

Study ID

NCT04905836

Start date

Nov 16, 2021

Status verified date

Apr, 2022

Completion date

Mar, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

placebo comparator: Placebo

Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

Interventions

COVI-MSC

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

Placebo

Excipient solution

Primary outcome measure

  • All-cause mortality rate at Day 28 [ Time Frame: Baseline through Day 28 ]
  • Incidence of all adverse events (AEs) (safety) [ Time Frame: Baseline through study completion at Day 90 ]
  • Incidence of treatment-emergent adverse events (safety) [ Time Frame: Baseline through study completion at Day 90 ]
  • Incidence of severe adverse events (safety) [ Time Frame: Baseline through study completion at Day 90 ]
  • Incidence of infusion-related adverse events (safety) [ Time Frame: Baseline to Hour 4 ]

Central Contacts and Locations

Central contacts

Mike Royal, MD

(858) 203-4100mroyal@sorrentotherapeutics.com

Locations

Teradan Clinical Trials LLC

Recruiting

Brandon, Florida, United States, 33511

Contacts

Daniel Lorch, MD

813-603-4509STUDIES@TERADANCLINICALTRIALS.COM

Sarasota Memorial Health Care System (SMH)

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Kirk Voelker, MD

941-917-2225

St Luke's Research

Recruiting

Boise, Idaho, United States, 83702

St. Luke's Boise

Recruiting

Boise, Idaho, United States, 83702

Contacts

Karen Miller, MD

208-381-7092

Ascension St. John

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Stacie Merritt, MSN, RN-BC

918-744-3426

Principal Investigator:

Jill Wenger, MD

PRX Research/Dallas Regional Medical Center

Recruiting

Mesquite, Texas, United States, 75149

Contacts

Muhammad Saeed, MD

214-320-7000

More Information

Sponsor

Sorrento Therapeutics, Inc.

Last update posted

Apr 11, 2022

Last verified

Apr, 2022

Keywords

  • covid-19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sorrento Therapeutics, Inc. on 2022-04-11.