Covid19Phase 2NCT04905836
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress
A Phase 2 study testing COVI-MSC in people with Covid19, run by Sorrento Therapeutics, Inc. at 6 sites in United States.
Trial summary
This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / 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
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Nov 2021to Mar 2023
- 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 (can be documented from inpatient medical record)
- Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- 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
- Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O
- A previous stem cell infusion unrelated to this trial
- Pregnant or breast feeding or planning for either during the study
- Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
- History of a splenectomy, lung transplant or lung lobectomy
Show all 11Show fewer
- Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
- 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) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing (eg, obstructive sleep apnea)
- Has any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
St Luke's Research
Boise, Idaho, 83702
Lejla Godusevic
- Recruiting
St. Luke's Boise
Boise, Idaho, 83702
Karen Miller, MD, 208-381-7092
- Recruiting
Teradan Clinical Trials LLC
Brandon, Florida, 33511
Daniel Lorch, MD, 813-603-4509, STUDIES@TERADANCLINICALTRIALS.COM
- Recruiting
PRX Research/Dallas Regional Medical Center
Mesquite, Texas, 75149
Muhammad Saeed, MD, 214-320-7000
- Recruiting
Sarasota Memorial Health Care System (SMH)
Sarasota, Florida, 34239
Kirk Voelker, MD, 941-917-2225
- Recruiting
Ascension St. John
Tulsa, Oklahoma, 74104
Stacie Merritt, MSN, RN-BC, 918-744-3426
Jill Wenger, MD
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 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.
Read the detailed description
This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory stress (ARD) / acute respiratory distress syndrome (ARDS).
Subjects will be randomized 1:1 COVI-MSC to placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.
- 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
Incidence of all adverse events (AEs) (safety)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Measured: Baseline through study completion at Day 90
Incidence of treatment-emergent adverse events (safety)
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Measured: Baseline through study completion at Day 90
Incidence of severe adverse events (safety)
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Measured: Baseline through study completion at Day 90
Incidence of infusion-related adverse events (safety)
Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours
Measured: Baseline to Hour 4
Secondary outcomes (5)
All-cause mortality rate at Day 60 and 90
All-cause mortality rate at Day 60 and 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 WHO Clinical Progression Scale (0-10 scale, where lower score means a better outcome) at Day 28
Measured: Baseline to Day 28
Change in oxygenation
Change in oxygenation as assessed using PaO2:FiO2 ratio
Measured: Baseline to Day 14 Day 28, and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start16 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
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
- 60 participants (estimated)
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
- NCT04905836
- Sponsor's protocol ID
- MSC-COV-202
- Status last verified
- Apr 2022
- First submitted
- 27 May 2021
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. 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
- NCT04905836
- Acronym / sponsor ID
- MSC-COV-202
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 28 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 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.
Detailed description
This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory stress (ARD) / acute respiratory distress syndrome (ARDS).
Subjects will be randomized 1:1 COVI-MSC to placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.
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 (can be documented from inpatient medical record)
- Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Requires oxygen supplementation at Screening
- Willing to follow contraception guidelines
Key exclusion criteria (11 listed)
- Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
- Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O
- A previous stem cell infusion unrelated to this trial
- Pregnant or breast feeding or planning for either during the study
- Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
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
Incidence of all adverse events (AEs) (safety)
Time frame: Baseline through study completion at Day 90
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Incidence of treatment-emergent adverse events (safety)
Time frame: Baseline through study completion at Day 90
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of severe adverse events (safety)
Time frame: Baseline through study completion at Day 90
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of infusion-related adverse events (safety)
Time frame: Baseline to Hour 4
Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours
5 secondary outcomes
All-cause mortality rate at Day 60 and 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 14 Day 28, and Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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 United States.
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 11 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Royal, MD ((858) 203-4100 ext. 4146, mroyal@sorrentotherapeutics.com), or a site near the patient. 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). The study lists 5 primary outcomes in all. 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 11 Apr 2022.