Clinical trial NCT04905836: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress
Official title: Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality rate at Day 28
timeFrame: Baseline through Day 28
measure: Incidence of all adverse events (AEs) (safety)
timeFrame: Baseline through study completion at Day 90
measure: Incidence of treatment-emergent adverse events (safety)
timeFrame: Baseline through study completion at Day 90
measure: Incidence of severe adverse events (safety)
timeFrame: Baseline through study completion at Day 90
measure: Incidence of infusion-related adverse events (safety)
timeFrame: Baseline to Hour 4
Secondary outcomes:
measure: All-cause mortality rate at Day 60 and 90
timeFrame: Baseline through Day 60 and Day 90
measure: Number of ventilator-free days through Day 28
timeFrame: Baseline through Day 28
measure: Number of ICU days through Day 28
timeFrame: Baseline through Day 28
measure: Change in clinical status
timeFrame: Baseline to Day 28
measure: Change in oxygenation
timeFrame: Baseline to Day 14 Day 28, and Day 60
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Teradan Clinical Trials LLC
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System (SMH)
state: Florida
city: Boise
country: United States
facility: St Luke's Research
state: Idaho
city: Boise
country: United States
facility: St. Luke's Boise
state: Idaho
city: Tulsa
country: United States
facility: Ascension St. John
state: Oklahoma
city: Mesquite
country: United States
facility: PRX Research/Dallas Regional Medical Center
state: Texas
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: