Clinical trial NCT04903327: Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress
Official title: Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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 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

Primary outcomes:
measure: All-cause mortality rate at Day 28
timeFrame: Baseline through Day 28
Secondary outcomes:
measure: All-cause mortality rate at Day 60 and Day 90
timeFrame: Baseline through Day 60 and Day 90
measure: Number of ventilator-free days through Day 28
timeFrame: Baseline through Day 28
measure: Number of ICU days through Day 28
timeFrame: Baseline through Day 28
measure: Change in clinical status
timeFrame: Baseline to Day 28
measure: Change in oxygenation
timeFrame: Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
state: BA
city: Salvador
country: Brazil
facility: Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
state: BA
city: Campinas
country: Brazil
facility: Saraiva & Berlinger Ltda. - EPP (IPECC)
state: SP
city: Jaú
country: Brazil
facility: CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
state: SP
city: São Bernardo Do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
state: SP
city: São Paulo
country: Brazil
facility: Impar Serviços Hospitalares S/A (Hospital Nove de Julho)
state: SP
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: