COVIDPhase 2NCT04389450
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
A Phase 2 study testing PLX-PAD in people with COVID and ARDS, run by Pluristem Ltd. at 13 sites in United States.
Trial summary
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- PLX-PAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Oct 2020to 7 Jun 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
- Male or non-pregnant female adult 40-80 years of age at time of enrollment.
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
- Meets definition of ARDS according to Berlin criteria.
Who cannot join
- Body weight under 55 kg (121 lbs)
- Serum creatinine level of over 1.5 mg/dL at time of randomization.
- Total Bilirubin ≥2 mg/dL at time of randomization.
- Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
- Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
- Chronic Obstructive Pulmonary disease GOLD stage above II.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Medical College of Georgia at Augusta University
Augusta, Georgia, 30907
Cooper Research Institute
Camden, New Jersey, 08103
University of California Irvine
Irvine, California, 92868
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Baptist Health Medical Center
Jacksonville, Florida, 32207
University of Southern California (USC) - Keck School of Medicine (KSOM)
Los Angeles, California, 90033
Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)
Macon, Georgia, 31217
Montefiore Medical Center
New York, New York, 10467
Maimonides Medical Center
New York, New York, 11219
Mercy Medical Center
New York, New York, 11570
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University Of California Davis,4860 Y Street
Sacramento, California, 95817
Holy Medical Center
Teaneck, New Jersey, 07666
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
- Being tested
- PLX-PAD, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX-PADBiological
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
PlaceboBiological
Placebo solution for injection
| Study group | Role | What they receive |
|---|---|---|
| PLX-PAD interval high dose | Experimental | PLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments. Receives: Biological: PLX-PAD |
| PLX-PAD low dose | Experimental | PLX-PAD 300, single administration, second administration of placebo after 1 week. Receives: Biological: PLX-PAD |
| Control Group A | Placebo comparator | Placebo, two administrations, 1 week apart Receives: Biological: Placebo |
| PLX-PAD high dose | Experimental | PLX-PAD, single administration Receives: Biological: PLX-PAD |
| Control Group B | Placebo comparator | Placebo, single administration Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator free days
Measured: 28 days
Secondary outcomes (2)
All-cause mortality
Measured: 28 days
Duration of mechanical ventilation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Oct 2020
- Primary completion17 May 2021
- Study completion7 Jun 2023
Why it stopped: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pluristem Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389450
- Sponsor's protocol ID
- PLX-COV-01
- Status last verified
- Aug 2024
- First submitted
- 14 May 2020
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04389450
- Acronym / sponsor ID
- PLX-COV-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pluristem Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 15 May 2020 (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 clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PLX-PAD interval high dose | Experimental | Biological: PLX-PADPLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments. |
| PLX-PAD low dose | Experimental | Biological: PLX-PADPLX-PAD 300, single administration, second administration of placebo after 1 week. |
| Control Group A | Placebo comparator | Biological: PlaceboPlacebo, two administrations, 1 week apart |
| PLX-PAD high dose | Experimental | Biological: PLX-PADPLX-PAD, single administration |
| Control Group B | Placebo comparator | Biological: PlaceboPlacebo, single administration |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
- Male or non-pregnant female adult 40-80 years of age at time of enrollment.
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
- Meets definition of ARDS according to Berlin criteria.
Key exclusion criteria (6 listed)
- Body weight under 55 kg (121 lbs)
- Serum creatinine level of over 1.5 mg/dL at time of randomization.
- Total Bilirubin ≥2 mg/dL at time of randomization.
- Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
- Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
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 |
|---|---|---|
| PLX-PADPLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells | Biological | PLX-PAD high dose, PLX-PAD interval high dose, PLX-PAD low dose |
| PlaceboPlacebo solution for injection | Biological | Control Group A, Control Group B |
Primary outcome
Number of ventilator free days
Time frame: 28 days
2 secondary outcomes
All-cause mortality
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
13 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 PLX-PAD in people with COVID and ARDS, run by Pluristem Ltd. at 13 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 6 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 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study was stopped early (reason given: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients). 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?
Number of ventilator free days (time frame: 28 days). 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 30 Aug 2024.