COVIDPhase 1NCT04397796

Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation

A Phase 1 study testing BM-Allo.MSC in people with COVID, run by ImmunityBio, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: COVID
What is being tested?: BM-Allo.MSC
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2020to 6 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. For subjects that are intubated and/or sedated, or otherwise unable to provide consent, prospective consent from a legally-authorized representative is required. The subject or his/her legally authorized representative must be able to provide consent.
Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
Requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by the Berlin criteria:
Bilateral opacities present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
Origin of Edema: Respiratory failure not fully explained by cardiac failure or fluid overload.

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Oxygenation: Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
Moderate: PaO2/FiO2 >100 mmHg and ≤ 200 mmHg, on ventilator settings that include PEEP ≥ 5 cm H2O
Severe: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O Subjects receiving extracorporeal membrane oxygenation (ECMO) will not be enrolled in this study.
High-sensitivity C-reactive Protein (hs-CRP) serum level > 4.0 mg/dL
Acute Physiology and Chronic Health Evaluation (APACHE IV) score > 5
Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of BM-Allo.MSC. Non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the dose of BM-Allo.MSC. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.

Who cannot join

Known hypersensitivity to any component of the study medication(s).
Signs of multisystem organ failure. Liver function tests (LFTs) > 5x normal.
Intubated > 72 continuous hours.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Pregnant and nursing women. A negative serum pregnancy test during screening (within 72 hours prior to the first dose) must be documented before MSCs are administered to a female subject of child-bearing potential.

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Francis Medical Center
Lynwood, California, 90262

Other trials in United States

About this study

Official title: Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation

Conditions: COVID
Being tested: BM-Allo.MSC, Placebo
Keywords: IMMUNOMODULATORY MESENCHYMAL STEM CELLS, MSC, COVID-19, Mechanical ventilation, Severe respiratory distress
Medical subject headings: COVID-19, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BM-Allo.MSCBiological
BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
PlaceboBiological
plasmalyte and human albumin

Study groups in NCT04397796
Study group	Role	What they receive
BM-Allo.MSC	Experimental	Subjects in the experimental arm will be administered BM-Allo.MSC Receives: Biological: BM-Allo.MSC
Placebo	Placebo comparator	Subjects in the control arm will be treated with placebo Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events Within 30 Days of Randomization
Incidence of AEs within 30 days of randomization.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 20206 Sep 2020

First posted21 May 2020
Study start3 Aug 2020
Primary completion6 Sep 2020
Study completion6 Sep 2020

Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVIDStudies of the same condition, open and under way.
More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04397796
Sponsor's protocol ID: QUILT-COVID-19-MSC
Status last verified: Apr 2024
First submitted: 18 May 2020
Last updated: 5 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation
ClinicalTrials.gov ID: NCT04397796
Acronym / sponsor ID: QUILT-COVID-19-MSC
Conditions: COVID
Keywords: IMMUNOMODULATORY MESENCHYMAL STEM CELLS, MSC, COVID-19, Mechanical ventilation, Severe respiratory distress
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Enrolment: 4 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 3 Aug 2020 (actual)
Primary completion: 6 Sep 2020 (actual)
Study completion: 6 Sep 2020 (actual)
First posted: 21 May 2020 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
BM-Allo.MSC	Experimental	Biological: BM-Allo.MSCSubjects in the experimental arm will be administered BM-Allo.MSC
Placebo	Placebo comparator	Biological: PlaceboSubjects in the control arm will be treated with placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. For subjects that are intubated and/or sedated, or otherwise unable to provide consent, prospective consent from a legally-authorized representative is required. The subject or his/her legally authorized representative must be able to provide consent.
Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
Requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by the Berlin criteria:
High-sensitivity C-reactive Protein (hs-CRP) serum level > 4.0 mg/dL

Key exclusion criteria (5 listed)

Known hypersensitivity to any component of the study medication(s).
Signs of multisystem organ failure. Liver function tests (LFTs) > 5x normal.
Intubated > 72 continuous hours.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Pregnant and nursing women. A negative serum pregnancy test during screening (within 72 hours prior to the first dose) must be documented before MSCs are administered to a female subject of child-bearing potential.

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
BM-Allo.MSCBM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.	Biological	BM-Allo.MSC
Placeboplasmalyte and human albumin	Biological	Placebo

Primary outcome

Number of Participants With Adverse Events Within 30 Days of Randomization
Time frame: 30 days
Incidence of AEs within 30 days of randomization.

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BM-Allo.MSC	3	0
Placebo	1	0

Primary outcome: Number of Participants With Adverse Events Within 30 Days of Randomization

Time frame: 30 days. Count of participants. Unit: Participants

Measure	BM-Allo.MSC n = 3	Placebo n = 1
Value	3	1

Population analysed: Analysis population is all randomized subjects who received at least one dose of study intervention (safety analysis population)

Adverse events

Time frame: From randomization through 30 days past the last dose, up to 34 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BM-Allo.MSC	3 of 3 (100%)	3 of 3 (100%)	3 of 3
Placebo	1 of 1 (100%)	1 of 1 (100%)	1 of 1

Limitations and caveats (from the sponsor): The study is terminated early due to low enrollment. Efficacy of the Investigational Product is not analyzed. Race was not collected in the CRFs for subjects and therefore is not presented in the data output for these subjects. Treatment-Emergent Adverse Events Table includes Serious Adverse Events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Enrolling by invitation
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BM-Allo.MSC in people with COVID, run by ImmunityBio, 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 14 inclusion and 5 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 5 Sep 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events Within 30 Days of Randomization (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397796.

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 5 Sep 2024.