Clinical trial NCT04728698: Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced 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Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
ARDS
Keywords: covid-19
ARDS
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-28
Enrollment: 0
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, 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.


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

Primary outcomes:
measure: Mortality at Day 28
timeFrame: Randomization through Day 28
Secondary outcomes:
measure: Mortality at Days 60 and 90
timeFrame: Randomization through Day 60 and Day 90
measure: Number of ventilator-free days
timeFrame: Randomization through Day 28
measure: Improvement in oxygenation
timeFrame: Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
measure: SOFA score at Day 28
timeFrame: Randomization to Day 28
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Fresno Community Hospital
state: California
Study officials:
affiliation: Sorrento Therapeutics
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: