Covid19
Conditions
Keywords
covid-19
Brief summary
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.
Detailed description
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4. Acceptable standard of care treatments for COVID-19 include all approved or emergency use authorized treatments for COVID-19, even if used off-label.
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 * Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300 * 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 * A previous stem cell infusion unrelated to this trial * Certain medical conditions that pose a safety risk to the subject * Pregnant or breast feeding or planning to during the study * Suspected uncontrolled active bacterial, fungal, viral, or other infection * History of splenectomy, lung transplant, or lung lobectomy * Concurrent participation in another clinical trial involving therapeutic interventions * 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) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate at Day 28 | Baseline through Day 28 | All-cause mortality rate at Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate at Day 60 and Day 90 | Baseline through Day 60 and Day 90 | All-cause mortality rate at Day 60 and Day 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 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome) |
| Change in oxygenation | Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28 | Change in oxygenation as assessed using PaO2:FiO2 ratio |
Countries
Brazil
Outcome results
None listed