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

Sponsor

Sorrento Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04903327

Collaborator

(none)

100

Enrollment

Locations

Arms

15.4

Anticipated Duration (Months)

16.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: COVI-MSC Drug: Placebo	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

All-cause mortality rate at Day 28 [Baseline through Day 28]
All-cause mortality rate at Day 28

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Sorrento Therapeutics, Inc.

Investigators

Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sorrento Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04903327

Other Study ID Numbers:

MSC-COV-201BR

First Posted:

May 26, 2021

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sorrento Therapeutics, Inc.

covid-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 16, 2022