Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for 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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04728698
• Other study ID #: MSC-COV-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2021
• Est. completion date: September 2021

Study information

• Verified date: September 2021
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provides informed consent

• Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen

• 3. Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 =300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas

• Requires oxygen supplementation at screening

• Is willing to follow contraception requirements

Exclusion Criteria:

• Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving

• A previous MSC infusion unrelated to this trial

• Have any of the following medical conditions:

• Cardio-pulmonary resuscitation within 14 days of randomization

• Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll

• Myocardial infarction within the last 6 weeks

• Congestive heart failure (NYHA Grade 3 or 4)

• Pulmonary hypertension (WHO Class III/IV)

• Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO)

• Alanine aminotransferase (ALT) = 5x upper limit of normal (ULN)

• Relevant renal impairment (eGFR < 50 mL/min)

• Any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study

• Pregnant or breast feeding or planning for either during the study

• Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)

• 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.

• Do Not Intubate order;

• Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Covid19

Intervention

Drug:
• COVI-MSC
1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level
• Placebo
Equivalent volume of placebo will be administered

Locations

Country	Name	City	State
United States	Fresno Community Hospital	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at Day 28	All-cause mortality at Day 28	Randomization through Day 28
Secondary	Mortality at Days 60 and 90	All-cause mortality at Days 60 and 90	Randomization through Day 60 and Day 90
Secondary	Number of ventilator-free days	Number of ventilator-free days through Day 28	Randomization through Day 28
Secondary	Improvement in oxygenation	Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2	Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
Secondary	SOFA score at Day 28	SOFA score at Day 28 compared to Baseline	Randomization to Day 28