Covid19Phase 2BRNCT04992247
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
A Phase 2 study testing COVI-MSC in people with Covid19, run by Sorrento Therapeutics, Inc..
Trial summary
This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Sep 2024
- 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
- Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
- Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
- Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
- Willing to follow contraception guidelines
Who cannot join
- Clinically improving pulmonary status over the month prior to screening
- Undergone 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
- Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
- History of a splenectomy, lung transplant or lung lobectomy
- Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
About this study
Official title: A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
Read the detailed description
This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.
- Conditions
- Covid19
- Being tested
- COVI-MSC, Placebo
- Keywords
- covid19, long haul, post-acute covid
- 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
2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group.
Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4
Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4
Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2
Group D: 2 MSC vials infused on D0, D2 and D4
PlaceboBiological
6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
| Study group | Role | What they receive |
|---|---|---|
| COVI-MSC | Experimental | Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) Receives: Biological: COVI-MSC |
| Placebo | Placebo comparator | Excipient Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Distance (6MWD) at Day 60
Change in 6MWD at Day 60
Measured: Baseline to Day 60
Secondary outcomes (5)
Change in 6MWD at Day 30
Change in 6MWD at Day 30
Measured: Baseline to Day 30
Relief of symptoms on Day 30 and Day 60
Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit
Measured: Baseline to Day 30 and Day 60
Change in Pulmonary Function
Change in pulmonary function at Days 30 and 60, as measured by the single-breath test
Measured: Baseline to Day 30 and Day 60
Change in oxygenation
Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio
Measured: Baseline to Day 30 and Day 60
Change in biomarker levels
Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
Measured: Baseline to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study startFeb 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
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
- 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992247
- Sponsor's protocol ID
- MSC-PLH-201BR
- Acronym
- BR
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2021
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
- ClinicalTrials.gov ID
- NCT04992247
- Acronym / sponsor ID
- BR / MSC-PLH-201BR
- Conditions
- Covid19
- Keywords
- covid19, long haul, post-acute covid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Aug 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 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
Detailed description
This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
COVI-MSC 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-MSCAllogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) |
| Placebo | Placebo comparator | Biological: PlaceboExcipient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
- Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
- Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
- Willing to follow contraception guidelines
Key exclusion criteria (7 listed)
- Clinically improving pulmonary status over the month prior to screening
- Undergone 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
- Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
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-MSC2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group. Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4 Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4 Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2 Group D: 2 MSC vials infused on D0, D2 and D4 | Biological | COVI-MSC |
| Placebo6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4. | Biological | Placebo |
Primary outcome
Change in 6-Minute Walk Distance (6MWD) at Day 60
Time frame: Baseline to Day 60
Change in 6MWD at Day 60
5 secondary outcomes
Change in 6MWD at Day 30
Time frame: Baseline to Day 30
Relief of symptoms on Day 30 and Day 60
Time frame: Baseline to Day 30 and Day 60
Change in Pulmonary Function
Time frame: Baseline to Day 30 and Day 60
Change in oxygenation
Time frame: Baseline to Day 30 and Day 60
Change in biomarker levels
Time frame: Baseline to Day 60
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 17 Apr 2024.
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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.
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..
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 7 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in 6-Minute Walk Distance (6MWD) at Day 60 (time frame: Baseline to Day 60). 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 17 Apr 2024.