Covid19
Conditions
Keywords
covid-19
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.
Interventions
BIOLOGICALCOVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
DRUGPlacebo
Excipient solution
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infusion-related adverse events (safety) | Baseline to Hour 4 | Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours |
| All-cause mortality rate at Day 28 | Baseline through Day 28 | All-cause mortality rate at Day 28 |
| Incidence of all adverse events (AEs) (safety) | Baseline through study completion at Day 90 | Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5) |
| Incidence of treatment-emergent adverse events (safety) | Baseline through study completion at Day 90 | Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria |
| Incidence of severe adverse events (safety) | Baseline through study completion at Day 90 | Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate at Day 60 and 90 | Baseline through Day 60 and Day 90 | All-cause mortality rate at Day 60 and 90 |
| Number of ventilator-free days through Day 28 | Baseline through Day 28 | Number of ventilator-free days through Day 28 |
| Number of ICU days through Day 28 | Baseline through Day 28 | Number of ICU days through day 28 |
| Change in clinical status | Baseline to Day 28 | Change in clinical status as assessed using the WHO Clinical Progression Scale (0-10 scale, where lower score means a better outcome) at Day 28 |
| Change in oxygenation | Baseline to Day 14 Day 28, and Day 60 | Change in oxygenation as assessed using PaO2:FiO2 ratio |
Countries
United States
Contacts
Primary ContactMike Royal, MD
Outcome results
None listed