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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04903327
• Other study ID #: MSC-COV-201BR
• Status: Terminated
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: November 23, 2022

Study information

• Verified date: January 2023
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: November 23, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Drug:
• Placebo
Excipient solution

Locations

Country	Name	City	State
Brazil	Saraiva & Berlinger Ltda. - EPP (IPECC)	Campinas	SP
Brazil	CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.	Jaú	SP
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)	Salvador	BA
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP	São Bernardo Do Campo	SP
Brazil	Impar Serviços Hospitalares S/A (Hospital Nove de Julho)	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate at Day 28	All-cause mortality rate at Day 28	Baseline through Day 28
Secondary	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
Secondary	Number of ventilator-free days through Day 28	Number of ventilator-free days through Day 28	Baseline through Day 28
Secondary	Number of ICU days through Day 28	Number of ICU days through Day 28	Baseline through Day 28
Secondary	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
Secondary	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