Covid19Phase 2NCT04728698
Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress
A Phase 2 study testing COVI-MSC in people with Covid19 and ARDS, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- COVI-MSC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2021to Sep 2021
- 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
- Provides informed consent
- Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
- 3. Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas
- Requires oxygen supplementation at screening
- Is willing to follow contraception requirements
Who cannot join
- Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
- A previous MSC infusion unrelated to this trial
- Have any of the following medical conditions:
- Cardio-pulmonary resuscitation within 14 days of randomization
- Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll
- Myocardial infarction within the last 6 weeks
Show all 19Show fewer
- Congestive heart failure (NYHA Grade 3 or 4)
- Pulmonary hypertension (WHO Class III/IV)
- Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO)
- Alanine aminotransferase (ALT) ≥ 5x upper limit of normal (ULN)
- Relevant renal impairment (eGFR < 50 mL/min)
- 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
- 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;
- 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.
- Do Not Intubate order;
- 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
Trial locations and contacts
1 site in 1 country.
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, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.
- Being tested
- COVI-MSC, Placebo
- Keywords
- covid-19, ARDS
- 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-MSCDrug
1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level
PlaceboDrug
Equivalent volume of placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| COVI-MSC | Experimental | Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) Receives: Drug: COVI-MSC |
| Placebo | Placebo comparator | Excipient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at Day 28
All-cause mortality at Day 28
Measured: Randomization through Day 28
Secondary outcomes (4)
Mortality at Days 60 and 90
All-cause mortality at Days 60 and 90
Measured: Randomization through Day 60 and Day 90
Number of ventilator-free days
Number of ventilator-free days through Day 28
Measured: Randomization through Day 28
Improvement in oxygenation
Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2
Measured: Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
SOFA score at Day 28
SOFA score at Day 28 compared to Baseline
Measured: Randomization to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Replaced by a different protocol.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728698
- Sponsor's protocol ID
- MSC-COV-201
- Status last verified
- Sep 2021
- First submitted
- 26 Jan 2021
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. 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
- NCT04728698
- Acronym / sponsor ID
- MSC-COV-201
- Keywords
- covid-19, ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced by a different protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Jan 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, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVI-MSC | Experimental | Drug: COVI-MSCAllogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) |
| Placebo | Placebo comparator | Drug: PlaceboExcipient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provides informed consent
- Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
- 3. Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas
- Requires oxygen supplementation at screening
- Is willing to follow contraception requirements
Key exclusion criteria (19 listed)
- Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
- A previous MSC infusion unrelated to this trial
- Have any of the following medical conditions:
- 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-MSC1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level | Drug | COVI-MSC |
| PlaceboEquivalent volume of placebo will be administered | Drug | Placebo |
Primary outcome
Mortality at Day 28
Time frame: Randomization through Day 28
All-cause mortality at Day 28
4 secondary outcomes
Mortality at Days 60 and 90
Time frame: Randomization through Day 60 and Day 90
Number of ventilator-free days
Time frame: Randomization through Day 28
Improvement in oxygenation
Time frame: Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
SOFA score at Day 28
Time frame: Randomization to Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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
1 site 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 and ARDS, run by Sorrento Therapeutics, Inc. at 1 site 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 5 inclusion and 19 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: withdrawn, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mortality at Day 28 (time frame: Randomization 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 16 Sep 2021.