Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-MSC | Experimental | 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 | Placebo Comparator | Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-MSC | Biological | COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality rate at Day 28 | All-cause mortality rate at Day 28 | Baseline through Day 28 |
| Incidence of all adverse events (AEs) (safety) | Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5) | Baseline through study completion at Day 90 |
| Incidence of treatment-emergent adverse events (safety) | Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria | Baseline through study completion at Day 90 |
| Incidence of severe adverse events (safety) | Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria | Baseline through study completion at Day 90 |
| Incidence of infusion-related adverse events (safety) | Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours | Baseline to Hour 4 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality rate at Day 60 and 90 | All-cause mortality rate at Day 60 and 90 | Baseline through Day 60 and Day 90 |
| Number of ventilator-free days through Day 28 | Number of ventilator-free days through Day 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mike Royal, MD | Contact | (858) 203-4100 | 4146 | mroyal@sorrentotherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teradan Clinical Trials LLC | Recruiting | Brandon | Florida | 33511 | United States |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Excipient solution |
|
| Baseline through Day 28 |
| Number of ICU days through Day 28 | Number of ICU days through day 28 | Baseline through Day 28 |
| Change in clinical status | 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 | Baseline to Day 28 |
| Change in oxygenation | Change in oxygenation as assessed using PaO2:FiO2 ratio | Baseline to Day 14 Day 28, and Day 60 |
| Sarasota Memorial Health Care System (SMH) | Recruiting | Sarasota | Florida | 34239 | United States |
|
| St Luke's Research | Recruiting | Boise | Idaho | 83702 | United States |
|
| St. Luke's Boise | Recruiting | Boise | Idaho | 83702 | United States |
|
| Ascension St. John | Recruiting | Tulsa | Oklahoma | 74104 | United States |
|
| PRX Research/Dallas Regional Medical Center | Recruiting | Mesquite | Texas | 75149 | United States |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |