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

NCT04903327 | Terminated Phase 2 FDA Drug

• 1 other identifier: MSC-COV-201BR
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

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.

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

• All-cause mortality rate at Day 28

  All-cause mortality rate at Day 28

  Baseline through Day 28

Secondary Outcomes (5)

• All-cause mortality rate at Day 60 and Day 90

  Baseline through Day 60 and Day 90

• Number of ventilator-free days through Day 28

  Baseline through Day 28

• Number of ICU days through Day 28

  Baseline through Day 28

• Change in clinical status

  Baseline to Day 28

• Change in oxygenation

  Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28

Study Arms (2)

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

Biological: COVI-MSC

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

COVI-MSC BIOLOGICAL

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

COVI-MSC

Placebo DRUG

Excipient solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (6)

Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino

Salvador, Estado de Bahia, Brazil

Location

Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)

Salvador, Estado de Bahia, Brazil

Location

Saraiva & Berlinger Ltda. - EPP (IPECC)

Campinas, São Paulo, Brazil

Location

CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.

Jaú, São Paulo, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP

São Bernardo do Campo, São Paulo, Brazil

Location

Impar Serviços Hospitalares S/A (Hospital Nove de Julho)

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: November 16, 2021
• Primary Completion: August 29, 2022
• Study Completion: November 23, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

BR (6)