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

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.

Purpose of Study

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.

Eligibility

Age:
18 +
Sex:
All

Key Inclusion / Exclusion Criteria

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

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

Conditions:

COVID-19

Status:

Recruiting

Phase:

Phase 2

Study ID

NCT04903327

Read Detailed Summary

Start Date / End Date:

16/11/2021 -

Enrollment:

100

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04903327

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6 Study Locations

Brazil

Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
Salvador, BA,
Brazil


Saraiva & Berlinger Ltda. – EPP (IPECC)
Campinas, SP,
Brazil


CECIP JAU – Centro de Estudos Clínicos do Interior Paulista Ltda.
Jaú, SP,
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,
Brazil


Hospital São Rafael S.A. – Instituto D’Or de Pesquisa e Ensino
Salvador, BA,
Brazil


Study Locations Map: