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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2022-11-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

COVI-MSC

Intervention Type BIOLOGICAL

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Excipient solution

Interventions

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COVI-MSC

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

Intervention Type BIOLOGICAL

Placebo

Excipient solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No