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

Sorrento Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Biological: COVI-MSC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04903327

MSC-COV-201BR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

COVI-MSC

Experimental group

Description:

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

Treatment:

Biological: COVI-MSC

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo