## Protocol Section
### Identification Module
**NCT ID:** NCT04909879

**Brief Title:** Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

**Official Title:** Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells

#### Organization Study ID Info
**ID:** MSC-ARDS-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Sorrento Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2022-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-24

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-17

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2022-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09

**Type:** ESTIMATED

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2021-06-02
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-29
**Study First Submit QC Date:** 2021-05-29
**Why Stopped:** Replaced by a different protocol.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sorrento Therapeutics, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

**Detailed Description:** 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 treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

### Conditions Module

**Conditions:**

- Acute Respiratory Distress Syndrome

- Ards

**Keywords:**

- ARDS

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Biological: COVI-MSC

**Label:** COVI-MSC

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- COVI-MSC

**Description:** COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

**Name:** COVI-MSC

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Excipient solution

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** All-cause mortality rate at Day 28

**Measure:** All-cause mortality rate at Day 28

**Time Frame:** Baseline to Day 28

#### Secondary Outcomes

**Description:** All-cause mortality rate at Days 60 and 90

**Measure:** All-cause mortality rate at Days 60 and 90

**Time Frame:** Baseline to Day 60 and Day 90

**Description:** Number of ventilator-free days through Day 28

**Measure:** Number of ventilator-free days through Day 28

**Time Frame:** Baseline through Day 28

**Description:** Number of ICU days through Day 28

**Measure:** Number of ICU days through Day 28

**Time Frame:** Baseline through Day 28

**Description:** Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)

**Measure:** Clinical status at Day 28

**Time Frame:** Baseline to Day 28

**Description:** Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.

**Measure:** Change in oxygenation

**Time Frame:** Baseline to Day 2, Day 4, Day 6, Day 14, Day 28

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Hospitalized with non-COVID-19-induced 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 ARDS appear to be working and the subject is clinically improving
* 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
* 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Sorrento Therapeutics, Inc.

**Name:** Mike Royal, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000055370

- Term: Lung Injury

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: LOW

- As Found: Unknown

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M28144

- Name: Acute Lung Injury

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: M28143

- Name: Lung Injury

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

- ID: D000055371

- Term: Acute Lung Injury

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
