Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Biological: COVI-MSC; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil
      • Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
    • Salvador, BA, Brazil
      • Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
  • SP
    • Campinas, SP, Brazil
      • Saraiva & Berlinger Ltda. - EPP (IPECC)
    • Jaú, SP, Brazil
      • CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
    • São Bernardo Do Campo, SP, Brazil
      • CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
    • São Paulo, SP, Brazil
      • Impar Serviços Hospitalares S/A (Hospital Nove de Julho)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVI-MSC; 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	Biological: COVI-MSC; COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Placebo Comparator: Placebo; Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4	Drug: Placebo; Excipient solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality rate at Day 28	All-cause mortality rate at Day 28	Baseline through Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ventilator-free days through Day 28	Number of ventilator-free days through Day 28	Baseline through Day 28
Number of ICU days through Day 28	Number of ICU days through Day 28	Baseline through Day 28
All-cause mortality rate at Day 60 and Day 90	All-cause mortality rate at Day 60 and Day 90	Baseline through Day 60 and Day 90
Change in clinical status	Change in clinical status as assessed using the 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome)	Baseline to Day 28
Change in oxygenation	Change in oxygenation as assessed using PaO2:FiO2 ratio	Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: covid-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MSC-COV-201BR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No