Covid19Phase 2NCT04903327
Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress
A Phase 2 study testing COVI-MSC in people with Covid19, run by Sorrento Therapeutics, Inc. at 6 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- COVI-MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 6 sitesBrazil
- Study dates
- 16 Nov 2021to 23 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Saraiva & Berlinger Ltda. - EPP (IPECC)
Campinas, São Paulo
CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
Jaú, São Paulo
Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia
Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
Salvador, Estado de Bahia
CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
São Bernardo do Campo, São Paulo
Impar Serviços Hospitalares S/A (Hospital Nove de Julho)
São Paulo, São Paulo
About this study
Official title: Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- COVI-MSC, Placebo
- Keywords
- covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVI-MSCBiological
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
PlaceboDrug
Excipient solution
| Study group | Role | What they receive |
|---|---|---|
| COVI-MSC | Experimental | 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 Receives: Biological: COVI-MSC |
| Placebo | Placebo comparator | Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate at Day 28
All-cause mortality rate at Day 28
Measured: Baseline through Day 28
Secondary outcomes (5)
All-cause mortality rate at Day 60 and Day 90
All-cause mortality rate at Day 60 and Day 90
Measured: Baseline through Day 60 and Day 90
Number of ventilator-free days through Day 28
Number of ventilator-free days through Day 28
Measured: Baseline through Day 28
Number of ICU days through Day 28
Number of ICU days through Day 28
Measured: Baseline through Day 28
Change in clinical status
Change in clinical status as assessed using the 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome)
Measured: Baseline to Day 28
Change in oxygenation
Change in oxygenation as assessed using PaO2:FiO2 ratio
Measured: Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start16 Nov 2021
- Primary completion29 Aug 2022
- Study completion23 Nov 2022
Why it stopped: Due to considerably slow enrollment, unable to reach enrollment targets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903327
- Sponsor's protocol ID
- MSC-COV-201BR
- Status last verified
- Jan 2023
- First submitted
- 21 May 2021
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04903327
- Acronym / sponsor ID
- MSC-COV-201BR
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to considerably slow enrollment, unable to reach enrollment targets
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVI-MSC | Experimental | Biological: COVI-MSCSubjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVI-MSCCOVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells | Biological | COVI-MSC |
| PlaceboExcipient solution | Drug | Placebo |
Primary outcome
All-cause mortality rate at Day 28
Time frame: Baseline through Day 28
All-cause mortality rate at Day 28
5 secondary outcomes
All-cause mortality rate at Day 60 and Day 90
Time frame: Baseline through Day 60 and Day 90
Number of ventilator-free days through Day 28
Time frame: Baseline through Day 28
Number of ICU days through Day 28
Time frame: Baseline through Day 28
Change in clinical status
Time frame: Baseline to Day 28
Change in oxygenation
Time frame: Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28
Results and safety
The study was stopped early (reason given: Due to considerably slow enrollment, unable to reach enrollment targets). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVI-MSC in people with Covid19, run by Sorrento Therapeutics, Inc. at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to considerably slow enrollment, unable to reach enrollment targets). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality rate at Day 28 (time frame: Baseline through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.